{"id":33035,"date":"2025-08-11T16:10:59","date_gmt":"2025-08-11T10:40:59","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=33035"},"modified":"2025-08-12T16:36:57","modified_gmt":"2025-08-12T11:06:57","slug":"promising-sarcopenia-drugs-in-development","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/promising-sarcopenia-drugs-in-development","title":{"rendered":"The Next Wave in Sarcopenia Drug Development: 5 Therapies to Look Out"},"content":{"rendered":"\n

Although there are no approved sarcopenia drugs at present, ongoing research is exploring possible pharmacological solutions. Investigational treatments include Selective Androgen Receptor Modulators (SARMs) and myostatin inhibitors<\/strong>, which aim to enhance muscle mass and function. Beyond non-pharmacological approaches, some individuals reported using a range of drug therapies and medical procedures to address sarcopenia or related conditions. These included ibutamoren, creatine, fluconazole, interferon, teriparatide, etanercept, as well as surgeries for arthritis, cancer, and cardiovascular disease. At the moment, the clinical sarcopenia pipeline<\/a> shows a notable absence of late-stage candidates. Given this gap, our projections take into account the potential influence of TNF Pharmaceuticals\u2019 MYMD-1, Lipocine\u2019s LPCN 1148, <\/strong>and Biophytis\u2019 BIO101<\/strong>.\u00a0Now let\u2019s dive in detail into the 5 promising sarcopenia drugs that could reshape the treatment landscape.<\/em><\/p>\n\n\n\n

TNF Pharmaceuticals\u2019 MYMD-1\/Iisomyosamine<\/strong><\/p>\n\n\n\n

MYMD-1<\/strong> is a first-in-class, orally administered TNF-\u03b1 inhibitor<\/strong> designed to treat a range of immune-metabolic disorders, including delayed aging, extended lifespan, and autoimmune diseases. In 2023, the drug successfully completed a small but statistically significant Phase II trial<\/strong> assessing its safety and efficacy for sarcopenia\u2014a progressive, age-related loss of muscle mass and strength. Unlike currently available TNF-\u03b1 blockers<\/a>, MYMD-1 can be taken orally and has been shown to lower TNF-\u03b1 levels and inflammation without requiring injections or infusions. The company now plans to advance the program into a Phase III trial, positioning MYMD-1 as a potential first FDA-approved treatment for sarcopenia.<\/p>\n\n\n\n

In January 2025, TNF Pharmaceuticals announced achieving a key safety milestone that supports expanding and extending clinical studies of isomyosamine across multiple indications. The previous month, in December 2024, the company presented encouraging top-line results from the Phase IIa trial of MYMD-1 at a leading international conference on sarcopenia and related conditions.<\/p>\n\n\n\n

Lipocine\u2019s LPCN 1148<\/strong><\/p>\n\n\n\n

LPCN 1148 <\/strong>is an oral prodrug of bioidentical testosterone currently being investigated in a Phase II Proof-of-Concept study<\/strong> in patients with decompensated cirrhosis. Results from this study showed that LPCN 1148 improved sarcopenia and related clinical outcomes. Positioned as a potential first-in-class therapy with a novel mechanism of action for cirrhosis management, Lipocine is now preparing for a Phase III trial. At present, participation in clinical studies is the primary means of accessing this investigational medicine.<\/p>\n\n\n\n

In December 2024, the U.S. FDA granted LPCN 1148 Fast Track Designation<\/strong> for treating sarcopenia in patients with decompensated cirrhosis. Earlier, in May 2024, Lipocine shared Phase II results in an oral presentation at the European Association for the Study of the Liver (EASL) Congress<\/em>.<\/p>\n\n\n\n

Biophytis\u2019 Sarconeos<\/strong><\/p>\n\n\n\n

Biophytis <\/strong>is developing Sarconeos (BIO101)<\/strong>, an oral small-molecule therapy for the treatment of neuromuscular disorders. By activating the MAS receptor<\/strong> in muscle cells, Sarconeos boosts biological resilience and helps maintain muscle function in age-related and muscle-wasting conditions.<\/p>\n\n\n\n

BIO101 (20-hydroxyecdysone) is the first sarcopenia drug candidate<\/a> to successfully complete a Phase II trial (SARA-INT)<\/strong>, showing encouraging results in improving mobility among elderly patients with sarcopenia. In the study, the treatment significantly increased walking speed in the 400-meter walk test (400MWT), the primary endpoint under per-protocol analysis. These benefits were also observed in obese sarcopenic patients, a high-risk subgroup.<\/p>\n\n\n\n

Biophytis remains the only biotech and pharmaceutical company to have secured EMA and FDA authorization to initiate a Phase III study in sarcopenia, the SARA-31 program<\/strong>, across Europe and the United States.<\/p>\n\n\n\n

\"Emerging-Therapies-for-Sarcopenia\"<\/a><\/figure>\n\n\n\n

Rejuvenate Biomed\u2019s RJx-01<\/strong><\/p>\n\n\n\n

RJx-01<\/strong> is a proprietary oral combination therapy designed to leverage the synergistic effects of two small molecules. It is patent-protected for multiple indications and has an established human safety profile. Preclinical studies demonstrated significant gains in muscle mass, strength, and physical performance in sarcopenia mouse models, supporting the predictive accuracy of the company\u2019s drug discovery platforms and expediting its progression into clinical evaluation.<\/p>\n\n\n\n

In a Phase Ib trial targeting disuse-induced muscle atrophy in healthy elderly participants, RJx-01 achieved all primary and secondary endpoints. The treatment was well tolerated, with no treatment-related serious or severe adverse events reported, and exhibited excellent bioavailability. Exploratory analyses indicated notable improvements in muscle strength, functional performance, and fatigue resistance.<\/p>\n\n\n\n

In May 2025, Rejuvenate Biomed announced that it had dosed the first patient in its Phase II clinical trial of RJx-01, the company\u2019s lead investigational compound, targeting muscle weakness and sarcopenia associated with chronic obstructive pulmonary disease (COPD).<\/p>\n\n\n\n

This trial is being conducted in collaboration with the University of Leicester, the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC), and Wellcome Leap Inc. It is led by Dr. Neil Greening and Dr. Hamish McCauley of the NIHR Leicester BRC at University Hospitals of Leicester NHS Trust.<\/p>\n\n\n\n

Keros Therapeutics\u2019 KER-065<\/strong><\/p>\n\n\n\n

KER-065 <\/strong>is an experimental, selective activin receptor ligand<\/strong> trap in development for neuromuscular disorders, with Duchenne muscular dystrophy (DMD) as the initial target. It works by blocking myostatin and activin A<\/strong>, key inhibitors of muscle and bone mass and strength, thereby promoting skeletal muscle regeneration, increasing muscle size and strength, reducing body fat, limiting muscle fibrosis, and enhancing bone strength. In March 2025, initial topline results from a Phase I clinical trial <\/strong>in healthy volunteers were released. <\/p>\n\n\n\n

The Phase I clinical trial of KER-065 is a randomized, double-blind, placebo-controlled study conducted in two parts, involving dose escalation through both single ascending doses and multiple ascending doses in healthy volunteers. Its primary goals are to evaluate the safety, tolerability, and pharmacokinetics of KER-065. Exploratory endpoints include examining its pharmacodynamic effects on bone, adipose tissue, muscle, cardiac tissue, and fibrosis. <\/p>\n\n\n\n

As of February 6, 2025, the data cut-off, KER-065 was generally well-tolerated, with no significant safety concerns, serious adverse events, or dose-limiting toxicities reported. Keros intends to begin discussions with regulatory authorities in the third quarter of 2025.<\/p>\n\n\n\n

Apart from these sarcopenia drugs, companies working on early-phase sarcopenia treatment drugs<\/a> include Oncocross<\/strong> (OC514), Mirscience Therapeutics<\/strong> (MT29) (Blocks MURF-1 and ATROGIN-1), Turn Biotechnologies <\/strong>(TRN-005) (RNA interference), NMD PHARMA<\/strong> (NMDP-05) (Chloride channel (ClC-1) inhibitors), ImmunoForge <\/strong>(PF1807) (GLP-1 receptor agonists), Dong Wha PHARM<\/strong> (DW1030) (Promotes mitochondrial function in muscle), and others with their candidates in different stages of clinical development.<\/p>\n\n\n\n

The sarcopenia treatment pipeline remains relatively limited, but growing awareness and the introduction of emerging sarcopenia therapies point toward steady market growth. As innovative approaches, ranging from pharmacological solutions to combination therapies, progress through clinical development, the potential to address existing unmet needs and establish effective management protocols continues to expand.<\/p>\n\n\n\n

\"Sarcopenia-Market-Outlook\"<\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"

Although there are no approved sarcopenia drugs at present, ongoing research is exploring possible pharmacological solutions. Investigational treatments include Selective Androgen Receptor Modulators (SARMs) and myostatin inhibitors, which aim to enhance muscle mass and function. Beyond non-pharmacological approaches, some individuals reported using a range of drug therapies and medical procedures to address sarcopenia or related 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