Press release
Fibromyalgia Competitive Landscape 2025: Clinical Trial Analysis, Therapies, FDA Approvals, Future Outlook by DelveInsight
Fibromyalgia Competitive Landscape
The Fibromyalgia Pipeline 2025 report provides an exhaustive evaluation of pipeline products, ranging from preclinical stages to marketed therapies. It includes comprehensive details on each drug's mechanism of action, clinical trial progress, NDA submissions or approvals, and product development activities such as technology deployment, collaborations, mergers and acquisitions, funding, and designations.
Download free sample report now - https://www.delveinsight.com/sample-request/fibromyalgia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Key Highlights from DelveInsight's Fibromyalgia Pipeline Report:
• Pharmaceutical companies worldwide are investing significantly in innovative Fibromyalgia therapies, achieving substantial progress over the years.
• Major players actively developing treatments include Tonix Pharmaceuticals, UCB Biopharma SRL, GlaxoSmithKline, Pierre Fabre Medicament, Eli Lilly and Company, Merck, Aptinyx, Astellas Pharma, AstraZeneca, RiboCor, Inc., Bial - Portela C S.A., and others.
• Notable emerging therapies across various clinical trial stages include TNX102 SL, Rozanolixizumab, Paroxetine CR, Lacosamide, Milnacipran, Rotigotine, Duloxetine, Saizen®, NYX-2925, ASP8062, Quetiapine, D-Ribose Powder, and ESL 400. These drugs are poised to significantly influence the Fibromyalgia treatment market in the near future.
• In June 2025, Axsome Therapeutics (NASDAQ: AXSM) received a Refusal to File (RTF) letter from the FDA for its NDA submission of AXS-14 (esreboxetine) targeting Fibromyalgia.
• TNX-102 SL, a sublingual tablet formulation of cyclobenzaprine hydrochloride (HCl) developed for bedtime use, demonstrates multi-receptor antagonism across serotonergic 5-HT2A, adrenergic α1, histaminergic H1, and muscarinic M1 receptors, offering a non-opioid approach to chronic pain management.
• Recent clinical evidence shows that adjunct M1-repetitive transcranial magnetic stimulation (rTMS) reduced pain for up to eight weeks in women with Fibromyalgia, with functional benefits lasting up to 16 weeks.
• Tonix Pharmaceuticals reported positive safety and tolerability results for TNX-201 in the Phase III RESILIENT trial (NCT05273749), demonstrating significant daily pain reduction versus placebo without impacting blood pressure or body weight. Female participants receiving TNX-102 also showed improvements in sexual function scores compared to placebo.
• The Phase III RESILIENT trial for TNX-102 SL 5.6 mg enrolled 457 patients across 33 U.S. sites to evaluate safety and efficacy in Fibromyalgia management, representing a significant advancement in treatment options.
Get a Free Sample PDF Report to know more about Fibromyalgia Pipeline Therapeutic Assessment-
https://www.delveinsight.com/report-store/fibromyalgia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Fibromyalgia Overview
Fibromyalgia is a chronic condition marked by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive challenges, and mood disorders. Though its precise etiology remains unclear, it is believed to result from a combination of genetic, environmental, and psychological factors. Patients commonly experience tender points, cognitive difficulties ("fibro fog"), disrupted sleep, fatigue, anxiety, and depression.
Emerging Fibromyalgia Drugs Across Clinical Development Phases:
• TNX102 SL - Tonix Pharmaceuticals
• Rozanolixizumab - UCB Biopharma SRL
• Paroxetine CR - GlaxoSmithKline
• Lacosamide - UCB Pharma
• Milnacipran - Pierre Fabre Medicament
• Rotigotine - UCB Pharma
• Duloxetine - Eli Lilly and Company
• Saizen® - Merck
• NYX-2925 - Aptinyx
• ASP8062 - Astellas Pharma
• Quetiapine - AstraZeneca
• D-Ribose Powder - RiboCor, Inc.
• ESL 400 - Bial - Portela C S.A
Further Fibromyalgia product details are provided in the report. Download the Fibromyalgia pipeline report to learn more about the emerging Fibromyalgia therapies
https://www.delveinsight.com/sample-request/fibromyalgia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Fibromyalgia Routes of Administration (ROA) in Pipeline Drugs:
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
Fibromyalgia Molecule Types in Development:
• Small molecules
• Monoclonal antibodies
• Recombinant fusion proteins
• Peptides
• Polymers
• Gene therapies
Fibromyalgia Therapeutic Assessment:
DelveInsight evaluates pipeline products based on stage, mechanism of action, route of administration, molecular type, and potential monotherapy or combination therapy applications. Products are segmented into preclinical, Phase I, Phase II, Phase III, and marketed stages, including discontinued or inactive candidates.
Fibromyalgia Market Players:
Key companies leading Fibromyalgia therapeutic development include Eli Lilly and Company, AbbVie, Teva Pharmaceutical Industries, Johnson & Johnson, Sanofi, GlaxoSmithKline, Pfizer, Bayer AG, TONIX Pharmaceuticals, Virios Therapeutics, Aptinyx, and FSD Pharma, among others.
Download Sample PDF Report to know more about Fibromyalgia drugs and therapies
https://www.delveinsight.com/sample-request/fibromyalgia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Fibromyalgia Pipeline Analysis:
The report provides detailed insights into:
• The total number of therapies under development by each company
• Segmentation of candidates across early-, mid-, and late-stage clinical development
• Active and inactive projects targeting Fibromyalgia
• Analysis based on route of administration, target receptors, mechanisms of action, and molecular type
• Overview of collaborations, licensing agreements, and funding arrangements supporting market growth
The insights are compiled from proprietary databases, company and academic websites, clinical trial registries, conference proceedings, SEC filings, investor presentations, and third-party sources.
Scope of the Fibromyalgia Pipeline Report:
• Coverage: Global
• Key Companies: Tonix Pharmaceuticals, UCB Biopharma SRL, GlaxoSmithKline, Pierre Fabre Medicament, Eli Lilly and Company, Merck, Aptinyx, Astellas Pharma, AstraZeneca, RiboCor, Inc., Bial - Portela C S.A., and others
• Key Therapies: TNX102 SL, Rozanolixizumab, Paroxetine CR, Lacosamide, Milnacipran, Rotigotine, Duloxetine, Saizen®, NYX-2925, ASP8062, Quetiapine, D-Ribose Powder, ESL 400
• Analysis: Current and emerging therapies, clinical stage, ROA, molecule type
• Market Dynamics: Drivers and barriers affecting Fibromyalgia therapy development
Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679
About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.
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