Fibromyalgia Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Fibromyalgia pipeline constitutes 8+ key companies continuously working towards developing 10+ Fibromyalgia treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Fibromyalgia Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

"Fibromyalgia Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Fibromyalgia Market.

Some of the key takeaways from the Fibromyalgia Pipeline Report: https://www.delveinsight.com/sample-request/fibromyalgia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Fibromyalgia treatment therapies with a considerable amount of success over the years.
• Fibromyalgia companies working in the treatment market are Tonix Pharmaceutical, 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, are developing therapies for the Fibromyalgia treatment
• Emerging Fibromyalgia therapies in the different phases of clinical trials are- TNX102 SL, Rozanolixizumab, Paroxetine CR, Lacosamide, milnacipran, Rotigotine, Duloxetine, Saizen®, NYX-2925, ASP8062, Quetiapine, D-Ribose Powder, ESL 400, and others are expected to have a significant impact on the Fibromyalgia market in the coming years.
• In June 2025, Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical firm at the forefront of CNS disorder treatments, announced today that the U.S. Food and Drug Administration (FDA) has issued a Refusal to File (RTF) letter regarding its New Drug Application (NDA) for AXS-14 (esreboxetine), aimed at treating fibromyalgia.
• In April 2025, TNX-102 SL is a centrally acting, non-opioid investigational medication intended for long-term use. It is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride (HCl), developed for bedtime administration to manage fibromyalgia. Cyclobenzaprine, a tertiary amine tricyclic compound, strongly binds and acts as an antagonist at four different post-synaptic neuroreceptor types: serotonergic 5-HT2A, adrenergic α1, histaminergic H1, and muscarinic M1-cholinergic receptors.
• In March 2025, Add-on M1-repetitive transcranial magnetic stimulation (rTMS) lowered pain levels for up to 8 weeks in women with fibromyalgia, with functional benefits persisting at 16 weeks, based on recent results from a randomized, double-blind clinical trial.
• In January 2024, Tonix Pharmaceuticals has announced further positive safety and tolerability findings for TNX-201, an investigational therapy, from a subsequent Phase III study focused on fibromyalgia. The topline results of the Phase III RESILIENT trial (NCT05273749), unveiled in December 2023, demonstrated the trial's success in achieving its predefined primary endpoint by notably alleviating daily pain compared to a placebo among fibromyalgia patients. Moreover, supplementary safety and tolerability assessments indicated that TNX-201 did not lead to elevated systolic or diastolic blood pressure or changes in body weight. Notably, in the Changes in Sexual Functioning Questionnaire (CSFQ-14), female participants receiving TNX-102 exhibited higher CSFQ-14 scores, suggesting potential improvements in sexual function compared to those on placebo.
• In November 2023, Tonix Pharmaceuticals has completed the clinical phase of the Phase III RESILIENT trial for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6mg, aimed at managing fibromyalgia. This multicenter trial, conducted across 33 sites in the US, enrolled 457 patients in a double-blind, placebo-controlled setting to assess the safety and efficacy of TNX-102 SL. The study involved a two-week run-in period where participants were randomly assigned to receive either TNX-102 SL 2.8mg or a placebo. The trial's objective was to evaluate TNX-102 SL's potential in managing fibromyalgia symptoms, marking a significant step in advancing treatment options for this challenging condition.

Fibromyalgia Overview
Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive issues. Its exact cause is unknown, but it's believed to involve a combination of genetic, environmental, and psychological factors. Common symptoms include widespread pain, tenderness in specific areas of the body known as tender points, fatigue, sleep disturbances, cognitive difficulties (often referred to as "fibro fog"), and mood disorders such as depression and anxiety.

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Emerging Fibromyalgia Drugs Under Different Phases of Clinical Development Include:
• TNX102 SL: Tonix Pharmaceutical
• Rozanolixizumab: UCB Biopharma SRL
• Paroxetine CR: GlaxoSmithKline
• Lacosamide: UCB Pharma
• milnacipran: Pierre Fabre Medicament
• Rotigotine: UCB Pharma
• Duloxetine: Eli Lilly and Company
• Saizen®: Merck
• TNX-102 SL: Tonix Pharmaceuticals, Inc.
• NYX-2925: Aptinyx
• ASP8062: Astellas Pharma
• Quetiapine: AstraZeneca
• D-Ribose Powder: RiboCor, Inc.
• ESL 400: Bial - Portela C S.A

Fibromyalgia 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Fibromyalgia Molecule Type
Fibromyalgia Products have been categorized under various Molecule types, such as
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Fibromyalgia Pipeline Therapeutics Assessment
• Fibromyalgia Assessment by Product Type
• Fibromyalgia By Stage and Product Type
• Fibromyalgia Assessment by Route of Administration
• Fibromyalgia By Stage and Route of Administration
• Fibromyalgia Assessment by Molecule Type
• Fibromyalgia by Stage and Molecule Type

DelveInsight's Fibromyalgia Report covers around 10+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

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=gpr

Some of the key companies in the Fibromyalgia Therapeutics Market include:
Key companies developing therapies for Fibromyalgia are - Eli Lilly and Company, AbbVie, Inc., Teva Pharmaceutical Industries Ltd., Johnson & Johnson Services, Inc., Sanofi, GlaxoSmithKline plc., Pfizer, Inc., Bayer AG, TONIX Pharmaceuticals Holdings Corp, Virios Therapeutics, Inc., Aptinyx Inc., FSD Pharma, and others.

Fibromyalgia Pipeline Analysis:
The Fibromyalgia pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Fibromyalgia with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Fibromyalgia Treatment.
• Fibromyalgia key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Fibromyalgia Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Fibromyalgia market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

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=gpr

Scope of Fibromyalgia Pipeline Drug Insight
• Coverage: Global
• Key Fibromyalgia Companies: Tonix Pharmaceutical, 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 Fibromyalgia Therapies: TNX102 SL, Rozanolixizumab, Paroxetine CR, Lacosamide, milnacipran, Rotigotine, Duloxetine, Saizen®, NYX-2925, ASP8062, Quetiapine, D-Ribose Powder, ESL 400, and others
• Fibromyalgia Therapeutic Assessment: Fibromyalgia current marketed and Fibromyalgia emerging therapies
• Fibromyalgia Market Dynamics: Fibromyalgia market drivers and Fibromyalgia market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

This release was published on openPR.