Fibromyalgia Pipeline Insight

DelveInsight’s, “Fibromyalgia – Pipeline Insight, 2021,” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Fibromyalgia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. 

Geography Covered

  • Global coverage

Fibromyalgia Understanding

Fibromyalgia: Overview

Fibromyalgia is a long-term (chronic) condition. It causes: pain in the muscles and bones (musculoskeletal pain), areas of tenderness, general fatigue, and sleep and cognitive disturbances. The pain and tenderness tend to come and go, and move about the body. Most often, people with this chronic (long-term) illness are fatigued (very tired) and have sleep problems. The diagnosis can be made with a careful examination. Fibromyalgia is most common in women, though it can occur in men. It most often starts in middle adulthood, but can occur in the teen years and in old age. The causes of fibromyalgia are unclear. They may be different in different people. Current research suggests involvement of the nervous system, particularly the central nervous system (brain and spinal cord). Fibromyalgia is not from an autoimmune, inflammation, joint, or muscle disorder. Fibromyalgia may run in families. There likely are certain genes that can make people more prone to getting fibromyalgia and the other health problems that can occur with it. Genes alone, though, do not cause fibromyalgia. There is no cure for fibromyalgia. However, symptoms can be treated with both non-drug and medication based treatments. Many times the best outcomes are achieved by using multiple types of treatments. Cognitive behavioral therapy is a type of therapy focused on understanding how thoughts and behaviors affect pain and other symptoms. CBT and related treatments, such as mindfulness, can help patients learn symptom reduction skills that lessen pain. The U.S. Food and Drug Administration has approved three drugs for the treatment of fibromyalgia. They include two drugs that change some of the brain chemicals (serotonin and norepinephrine) that help control pain levels: duloxetine (Cymbalta) and milnacipran (Savella). The other drug approved for fibromyalgia is pregabalin (Lyrica). Pregabalin and another drug, gabapentin (Neurontin), work by blocking the over activity of nerve cells involved in pain transmission. These medicines may cause dizziness, sleepiness, swelling and weight gain.


"Fibromyalgia - Pipeline Insight, 2021" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Fibromyalgia pipeline landscape is provided which includes the disease overview and Fibromyalgia treatment guidelines. The assessment part of the report embraces, in depth Fibromyalgia commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Fibromyalgia collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Fibromyalgia R&D. The therapies under development are focused on novel approaches to treat/improve Fibromyalgia.

Fibromyalgia Emerging Drugs Chapters

This segment of the Fibromyalgia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.


Fibromyalgia Emerging Drugs


TNX-102: Tonix Pharmaceuticals

Tonix is developing TNX-102 SL as a potential treatment for the symptoms of Fibromyalgia. It is currently in Phase 3 clinical development. TNX-102 SL targets mechanisms which are associated with disturbed sleep. It is believed that increasing sleep quality in fibromyalgia may facilitate the body's adaptive ability to modulate the perception of pain. TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. The dose of TNX-102 SL being studied in fibromyalgia is two tablets, or 5.6 mg of cyclobenzaprine each night at bedtime.


IMC1: Virios Therapeutics

IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 (“HSV-1”) activation and replication, with the end goal of reducing viral mediated disease burden. MC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or “down-regulating” HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 (“COX-2”) and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. “Composition of Matter” Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib. The drug is being evalauated in Phase II stage of development for the treatment of Fibromyalgia.

Further product details are provided in the report……..

Fibromyalgia: Therapeutic Assessment

This segment of the report provides insights about the different Fibromyalgia drugs segregated based on following parameters that define the scope of the report, such as:

  • Major Players in Fibromyalgia

There are approx. 15+ key companies which are developing the therapies for Fibromyalgia. The companies which have their Fibromyalgia drug candidates in the most advanced stage, i.e. Phase III include, Tonix Pharmaceuticals.

Phases

DelveInsight’s report covers around 15+ products under different phases of clinical development like

  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Route of Administration


Fibromyalgia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Oral
  • Parenteral
  • Intravenous
  • Subcutaneous
  • Topical
  • Molecule Type


Products have been categorized under various Molecule types such as

  • Monoclonal Antibody
  • Peptides
  • Polymer
  • Small molecule
  • Gene therapy
  • Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Fibromyalgia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Fibromyalgia therapeutic drugs key players involved in developing key drugs.


Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Fibromyalgia drugs.

Fibromyalgia Report Insights

  • Fibromyalgia Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Fibromyalgia Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Fibromyalgia drugs?
  • How many Fibromyalgia drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Fibromyalgia?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Fibromyalgia therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Fibromyalgia and their status?
  • What are the key designations that have been granted to the emerging drugs?

Introduction

Executive Summary

Fibromyalgia: Overview

  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

Pipeline Therapeutics

  • Comparative Analysis

Therapeutic Assessment

  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type

Late Stage Products (Phase III)

  • Comparative Analysis

TNX-102: Tonix Pharmaceuticals

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

  • Comparative Analysis

IMC1: Virios Therapeutics

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Preclinical stage products

  • Comparative Analysis

ARD-301: Sorrento Therapeutics

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

  • Comparative Analysis

Fibromyalgia Key Companies

Fibromyalgia Key Products

Fibromyalgia- Unmet Needs

Fibromyalgia- Market Drivers and Barriers

Fibromyalgia- Future Perspectives and Conclusion

Fibromyalgia Analyst Views

Fibromyalgia Key Companies

Appendix

List of Table

Table 1: Total Products for Fibromyalgia

Table 2: Late Stage Products

Table 3: Mid Stage Products

Table 4: Early Stage Products

Table 5: Pre-clinical & Discovery Stage Products

Table 6: Assessment by Product Type

Table 7: Assessment by Stage and Product Type

Table 8: Assessment by Route of Administration

Table 9: Assessment by Stage and Route of Administration

Table 10: Assessment by Molecule Type

Table 11: Assessment by Stage and Molecule Type

Table 12: Inactive Products

List of Figures

Figure 1: Total Products for Fibromyalgia

Figure 2: Late Stage Products                             

Figure 3: Mid Stage Products

Figure 4: Early Stage Products

Figure 5: Preclinical and Discovery Stage Products

Figure 6: Assessment by Product Type

Figure 7: Assessment by Stage and Product Type

Figure 8: Assessment by Route of Administration

Figure 9: Assessment by Stage and Route of Administration

Figure 10: Assessment by Molecule Type

Figure 11: Assessment by Stage and Molecule Type

Figure 12: Inactive Products   

• Tonix Pharmaceuticals

• Aptinyx

• Virios Therapeutics, Inc.

• Teva Pharmaceuticals

• Knop Laboratorios

• Integrated Tissue Dynamics, LLC

• Axsome

• Sorrento Therapeutics

• Imbrium Therapeutics

• Cytocom Inc.,

• Cortene Inc.,

• Intec Pharma

• Luye Pharma

  • Tags:
  • Fibromyalgia Pipeline
  • Fibromyalgia clinical trials
  • Fibromyalgia companies
  • Fibromyalgia drugs
  • Fibromyalgia therapies
  • Fibromyalgia treatment algorithm
  • Fibromyalgia pipeline drugs
  • Fibromyalgia pipeline companies

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