{"id":28430,"date":"2024-09-24T17:32:00","date_gmt":"2024-09-24T12:02:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=28430"},"modified":"2024-09-24T18:00:57","modified_gmt":"2024-09-24T12:30:57","slug":"evolving-amyotrophic-lateral-sclerosis-treatment-landscape","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/evolving-amyotrophic-lateral-sclerosis-treatment-landscape","title":{"rendered":"Unveiling Amyotrophic Lateral Sclerosis (ALS) Treatment Frontiers: Navigating Challenges, Overcoming Setbacks, and Emerging Therapeutic Horizons"},"content":{"rendered":"\n<p><em>DelveInsight forecasts that with the launch of <\/em><strong><em>15+<\/em><\/strong><em> emerging therapies alongside existing treatments, the ALS treatment market is anticipated to surpass <\/em><strong><em>USD 4 billion<\/em><\/strong><em> across the 7MM by 2034.<\/em><\/p>\n\n\n\n<p>Currently, there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. As per our analysis, the <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-epidemiology-forecast\">diagnosed prevalent cases of ALS<\/a> in the US were nearly <strong>24K<\/strong> in 2023. Therefore, the management of ALS remains supportive and symptom-based. The approved drugs to treat ALS include <strong>RILUZOLE, RADICAVA, TIGLUTIK, EXSERVAN, and QALSODY<\/strong>.&nbsp; Riluzole, the first approved drug for the treatment of ALS, has since been recommended as first-line therapy for ALS in many countries. Having been available in the US for over two decades, riluzole is now offered in generic forms as well. TIGLUTEK\/TEGLUTIK and EXSERVAN are various branded formulations of this medication.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-radicava-evolving-sales-trends-and-the-rise-of-radicava-ors-in-als-treatment\"><strong>RADICAVA: Evolving Sales Trends and the Rise of RADICAVA ORS in ALS Treatment<\/strong><\/h2>\n\n\n\n<p>RADICAVA (edaravone), the second approved <a href=\"https:\/\/www.delveinsight.com\/blog\/amyotrophic-lateral-sclerosis-treatment\">drug for treating ALS patients<\/a>, arrived on the market decades later with a notably high price tag. Following acute stroke approval, it was approved for the treatment of ALS in Japan in June 2015. Later, the FDA approved RADICAVA in May 2017. In the US, however, due to its high cost and insurance policies, RADICAVA\u2019s use has been limited to patients in the early stages of ALS. Given the clear need for further evidence of RADICAVA\u2019S effectiveness, in May 2019, <strong>Mitsubishi Tanabe Pharma GmbH<\/strong>&nbsp;notified the CHMP of its will to withdraw its application for a marketing license for RADICAVA to treat ALS.&nbsp;<\/p>\n\n\n\n<p>Analysis of RADICAVA\u2019s global sales revealed a decline from approximately <strong>USD ~200 million<\/strong> in 2020 to <strong>USD ~110 million<\/strong> in 2022. The drug\u2019s IV administration and the introduction of RADICUT generics in Japan contributed to this trend. Mitsubishi addressed this issue by developing RADICAVA ORS, an oral suspension, which was recently approved in May 2022 in the United States and in December 2022 in Japan. This approval of RADICAVA ORS led to a significant sales increase, with projected revenues of <strong>USD 900 million<\/strong> by 2034 across major markets, as per DelveInsight. However, the chances of getting launched in Europe remain uncertain.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-relyvrio-a-rollercoaster-journey-of-approval-acceptance-and-withdrawal-nbsp\"><strong>RELYVRIO: A Rollercoaster Journey of Approval, Acceptance, and Withdrawal&nbsp;<\/strong><\/h2>\n\n\n\n<p><strong>RELYVRIO<\/strong> received <strong>FDA approval in September 2022<\/strong> based on data from a <strong>Phase II CENTAUR trial<\/strong>. Originally, the FDA had not planned on reviewing RELYVRIO\u2019S application until data from the PHOENIX trial became available. However, the agency reconsidered in the wake of pushback from patient advocacy groups. Earlier, in March 2022, the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) voted against RELYVRIO due to insufficient data establishing its effectiveness. Concerns were raised about the robustness of AMX0035\u2019s data and high ALSFRS-R scores in the placebo group. However, in early September 2022, the committee voted in favor of AMX0035, announcing that the available evidence of effectiveness was sufficient to support its approval. The lack of <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-market\">ALS treatment options<\/a> led to a wave of support for RELYVRIO.<\/p>\n\n\n\n<p>RELYVRIO gained rapid acceptance in the US market from 2022 to 2023. However, the FDA\u2019s approval of RELYVRIO allowed Amylyx to make tens of millions of dollars in profits from selling a drug that turned out to be worthless. Amylyx charged <strong>USD 163,000<\/strong> a year for RELYVRIO, leading to <strong>USD 380.8 million<\/strong> in sales in 2023 and <strong>USD 22.2 million<\/strong> in 2022. About <strong>4,000<\/strong> patients in the United States received the treatment. Individuals and payors needlessly spent hundreds of millions of dollars, unjustly enriching the company. All these consequences were preventable, and the FDA needs to take steps to ensure that it never again approves a drug without clear evidence of efficacy.<\/p>\n\n\n\n<p>Across the pond, drug reviewers at the European Medicines Agency confirmed their rejection of the drug under the brand name <strong>ALBRIOZA<\/strong> in October 2023 after Amylyx appealed a previous negative opinion. Following recently presented topline results from the PHOENIX trial, which did not meet the prespecified primary or secondary endpoints, Amylyx Pharmaceuticals announced the removal of RELYVRIO from the ALS treatment market. The drug is no longer available to patients as of April 4, 2024, following several discussions between Amylyx, the US FDA, and Health Canada. However, patients currently on RELYVRIO in the US and Canada have the option to continue taking it as part of a free drug program.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-als-treatment-landscape-setbacks-and-new-hope-on-the-horizon-nbsp\"><strong>ALS Treatment Landscape: Setbacks and New Hope on the Horizon<\/strong><strong>&nbsp;<\/strong><\/h2>\n\n\n\n<p>The withdrawal of RELYVRIO is a big blow to the <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-epidemiology-forecast\">ALS patient<\/a> community, leaving behind just three\u00a0ALS medicines\u00a0available to US patients, only one of which has been shown to extend survival by several months. However, there has been one bit of good news with the FDA approval last year of <strong>Biogen\u2019s\u00a0QALSODY\u00a0<\/strong>(tofersen) for ALS associated with a mutation in the <strong><em>SOD1<\/em> gene<\/strong>, which accounts for around <strong>2%<\/strong> of all ALS cases. This approval marks a significant advancement in the treatment options available for ALS patients with specific genetic mutations. Biogen receives EMA CHMP recommendation for ALS treatment drug QALSODY. The<strong> <\/strong>decision on the marketing authorization for QALSODY is expected in Q2 2024.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"534\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24174623\/ALS-Market-Assessment-1024x534.jpg\" alt=\"\" class=\"wp-image-29743\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24174623\/ALS-Market-Assessment-1024x534.jpg 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24174623\/ALS-Market-Assessment-300x157.jpg 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24174623\/ALS-Market-Assessment-150x78.jpg 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24174623\/ALS-Market-Assessment-768x401.jpg 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24174623\/ALS-Market-Assessment-1536x802.jpg 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24174623\/ALS-Market-Assessment-2048x1069.jpg 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>After the setback with RELYVRIO, RADICAVA emerges as the leading contender in the current ALS market and is anticipated to achieve the highest revenue. However, it is not the end of the road for Amylyx and ALS. Its candidate AMX0114, an antisense oligonucleotide targeting calpain-2, is set to be evaluated in a first-in-human trial in the second half of 2024.<\/p>\n\n\n\n<p>Although the <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-pipeline-insight\">ALS pipeline<\/a> holds multiple promising therapies such as <strong>Masitinib <\/strong>(AB Science),<strong> Ibudilast <\/strong>(MediciNova),<strong> Ulefnersen <\/strong>(Ionis Pharmaceuticals), <strong>TPN-101 <\/strong>(Transposon Therapeutics) and other various stages of development, the <strong>failure rates of clinical trials are quite high for ALS. <\/strong>Therapies like <strong>arimoclomol <\/strong>(Orphazyme),<strong> levosimendan <\/strong>(Orion Pharmaceuticals),<strong> ravulizumab <\/strong>(Ultomiris),<strong> <\/strong>and<strong> Zilucoplan <\/strong>(UCB Pharma), are some recent failures in the list of therapies for ALS, and more may follow in the future.<\/p>\n\n\n\n<p><span id=\"docs-internal-guid-f6d1a961-7fff-98cb-573c-cc124321ef25\"><\/span><\/p>\n<div dir=\"ltr\" style=\"margin-left: 0pt;\" align=\"left\">\n<table style=\"border: none; border-collapse: collapse;\"><colgroup><col width=\"92\" \/><col width=\"129\" \/><col width=\"95\" \/><col width=\"88\" \/><col width=\"57\" \/><col width=\"141\" \/><\/colgroup>\n<tbody>\n<tr style=\"height: 7.7pt;\">\n<td style=\"vertical-align: top; background-color: #bfe6ff; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"6\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Some of the promising emerging assets in the ALS treatment pipeline<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 4.65pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Drug<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Company<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Molecule type<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Mutation<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Phase<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Anticipated US Launch<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 15.05pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Ulefnersen<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Ionis Pharmaceuticals<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Antisense RNA<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">FUS-ALS<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">III<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">2027<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 15.05pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Masitinib<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">AB Science<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Small molecule<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">&#8211;<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">III<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">2026<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 15.45pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Ibudilast<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">MediciNova<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Small molecule<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">&#8211;<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">II\/III<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">2025<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 15.45pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">CNM-Au8<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Clene Nanomedicine<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Gold nano crystals<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">&#8211;<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">II\/III<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">2026<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 14.65pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">TPN-101<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Transposon Therapeutics<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Small molecule<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">C9orf72-ALS<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">IIa<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">2028<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 4.45pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"6\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: italic; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">*List to be continued&hellip;<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The high failure rate in <a href=\"https:\/\/www.delveinsight.com\/blog\/evolving-als-treatment-landscape\">ALS clinical trials<\/a> is often attributed to the disease\u2019s unclear etiology and complex pathophysiology. Thus far in Q1 2024, both Sanofi and Denali Therapeutics\u2019 SAR443820, as well as Ferrer Internacional\u2019s FAB122, have failed to achieve their primary endpoints in Phase II and III studies, respectively. This is following the failure of Cytokinetics\u2019 reldesemtiv in March 2023 and BrainStorm Cell Therapeutics\u2019 NurOwn in September 2023. However, unlike Ferrer and Cytokinetics, BrainStorm Cell Therapeutics is still fighting for NurOwn, as the company will be initiating a Phase IIIb study for ALS in 2024.&nbsp;<\/p>\n\n\n\n<p>Despite the challenges and setbacks in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-market\">ALS treatment landscape<\/a>, the approval of drugs like Radicava ORS and QALSODY, along with a promising pipeline of emerging therapies, offer hope for improving the lives of ALS patients. However, the high failure rates in clinical trials and the need for clear evidence of efficacy highlight the ongoing challenges in developing effective treatments for this complex and devastating disease.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-market\"><img decoding=\"async\" width=\"1024\" height=\"194\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24170045\/Amyotrophic-Lateral-Sclerosis-Market-Outlook-1024x194.jpg\" alt=\"Amyotrophic-Lateral-Sclerosis-Market-Outlook\" class=\"wp-image-29728\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24170045\/Amyotrophic-Lateral-Sclerosis-Market-Outlook-1024x194.jpg 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24170045\/Amyotrophic-Lateral-Sclerosis-Market-Outlook-300x57.jpg 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24170045\/Amyotrophic-Lateral-Sclerosis-Market-Outlook-150x28.jpg 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24170045\/Amyotrophic-Lateral-Sclerosis-Market-Outlook-768x145.jpg 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24170045\/Amyotrophic-Lateral-Sclerosis-Market-Outlook-1536x291.jpg 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/24170045\/Amyotrophic-Lateral-Sclerosis-Market-Outlook.jpg 1584w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>DelveInsight forecasts that with the launch of 15+ emerging therapies alongside existing treatments, the ALS treatment market is anticipated to surpass USD 4 billion across the 7MM by 2034. Currently, there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. As per our analysis, the diagnosed [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":29748,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[74,19150,19151,16807,16808,19149,19148,22159,22160,22157,22156,22158],"industry":[17225],"therapeutic_areas":[17245],"class_list":["post-28430","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-amyotrophic-lateral-sclerosis","tag-amyotrophic-lateral-sclerosis-clinical-trials","tag-amyotrophic-lateral-sclerosis-emerging-drugs","tag-amyotrophic-lateral-sclerosis-market","tag-amyotrophic-lateral-sclerosis-pipeline","tag-amyotrophic-lateral-sclerosis-therapeutics","tag-amyotrophic-lateral-sclerosis-treatment","tag-exservan","tag-qalsody","tag-radicava","tag-riluzole","tag-tiglutik","industry-pharmaceutical","therapeutic_areas-neurology"],"acf":[],"yoast_head":"<!-- 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class=\"advgb-post-tax-term\">Amyotrophic lateral sclerosis market<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Amyotrophic lateral sclerosis pipeline<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Amyotrophic Lateral Sclerosis therapeutics<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Amyotrophic Lateral Sclerosis treatment<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">EXSERVAN<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">QALSODY<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">RADICAVA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">RILUZOLE<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">TIGLUTIK<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">amyotrophic lateral sclerosis<\/span>","<span class=\"advgb-post-tax-term\">Amyotrophic Lateral Sclerosis clinical trials<\/span>","<span class=\"advgb-post-tax-term\">Amyotrophic Lateral Sclerosis emerging drugs<\/span>","<span class=\"advgb-post-tax-term\">Amyotrophic lateral sclerosis market<\/span>","<span class=\"advgb-post-tax-term\">Amyotrophic lateral sclerosis pipeline<\/span>","<span class=\"advgb-post-tax-term\">Amyotrophic Lateral Sclerosis therapeutics<\/span>","<span class=\"advgb-post-tax-term\">Amyotrophic Lateral Sclerosis treatment<\/span>","<span class=\"advgb-post-tax-term\">EXSERVAN<\/span>","<span class=\"advgb-post-tax-term\">QALSODY<\/span>","<span class=\"advgb-post-tax-term\">RADICAVA<\/span>","<span class=\"advgb-post-tax-term\">RILUZOLE<\/span>","<span class=\"advgb-post-tax-term\">TIGLUTIK<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 2 years ago","modified":"Updated 2 years ago"},"absolute_dates":{"created":"Posted on Sep 24, 2024","modified":"Updated on Sep 24, 2024"},"absolute_dates_time":{"created":"Posted on Sep 24, 2024 5:32 pm","modified":"Updated on Sep 24, 2024 6:00 pm"},"featured_img_caption":"Unveiling Amyotrophic Lateral Sclerosis (ALS) Treatment 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