DelveInsight’s, “Fibromyalgia Pipeline Insight 2026” report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Fibromyalgia pipeline landscape. It covers the Fibromyalgia pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Fibromyalgia pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Curious about the latest updates in the Fibromyalgia Pipeline? @ https://www.delveinsight.com/sample-request/fibromyalgia-pipeline-insight

Key Takeaways from the Fibromyalgia Pipeline Report

• In March 2026- Ono Pharmaceutical Co., Ltd. initiated a phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients With Fibromyalgia.
• In February 2026- Axsome Therapeutics Inc. announced a phase 3 study is a multi-center trial consisting of a 12-week open-label treatment period (OLP), followed by a 12-week double-blind, placebo-controlled, randomized withdrawal period (DBRWP). During the OLP, subjects receive open-label AXS-14. Subjects achieving treatment response will be randomized into the DBRWP in a 1:1 ratio to either continue on AXS-14 or switch to placebo for up to 12 weeks or until a loss of therapeutic response occurs.
• DelveInsight’s Fibromyalgia Pipeline report depicts a robust space with 8+ active players working to develop 10+ pipeline therapies for Fibromyalgia treatment.
• The leading Fibromyalgia Companies such as UCB Biopharma SRL, Tonix Pharmaceuticals, Inc., Dogwood Therapeutics, Silo Pharma and others.
• Promising Fibromyalgia Therapies such as Paroxetine CR, Lacosamide, Milnacipran, Rotigotine, Duloxetine, Rozanolixizumab, ONO-1110 and others.

Want to know which companies are leading innovation in Fibromyalgia? @ Fibromyalgia Clinical Trials Assessment

The Fibromyalgia Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Fibromyalgia Pipeline Report also highlights the unmet needs with respect to the Fibromyalgia.

Fibromyalgia Overview

Fibromyalgia Syndrome (FMS) is a chronic condition characterized by widespread musculoskeletal pain, often accompanied by fatigue, sleep disturbances, cognitive dysfunction (fibro fog), and mood disorders such as anxiety and depression. Although the exact cause remains unclear, FMS is thought to result from a combination of genetic, neurobiological, and environmental factors that lead to alterations in pain processing and central sensitization, where the nervous system becomes hypersensitive to pain signals. Affecting approximately 6% to 15% of the population, with a notably higher prevalence in women, fibromyalgia significantly impacts daily life, making routine activities challenging and often leading to impaired physical, emotional, and social functioning.

Fibromyalgia Emerging Drugs

• TNX-102 SL: Tonix Pharmaceuticals, Inc.

TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique patented 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. TNX-102 SL is a centrally acting analgesic that helps in relieving pain by improving sleep. As a multifunctional agent with potent binding and antagonist activities at the serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development and has active IND’s as a daily bedtime treatment for fibromyalgia. Currently, the drug is in Preregistration stage of its clinical trial for the treatment of Fibromyalgia.

• Rozanolixizumab: UCB Biopharma SRL

Rozanolixizumab is an investigational humanized monoclonal antibody that specifically binds to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and IgG, inhibiting IgG recycling and inducing the removal of pathogenic IgG autoantibodies. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Fibromyalgia.

• IMC-1: Dogwood Therapeutics

IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1, combines 2 specific mechanisms of action purposely designed 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 replication and thus inhibits upregulation of the HSV-1 virus. The celecoxib component of IMC-1 inhibits cyclooxegenase-2 (COX-2) and to a lesser degree COX-1, enzymes used by HSV-1 to amplify or accelerate its own replication. Currently, the drug is in the Phase II stage of development to treat Fibromyalgia.

If you’re tracking ongoing Fibromyalgia Clinical trials, this press release is a must-read @ Fibromyalgia Treatment Drugs

Fibromyalgia Companies

UCB Biopharma SRL, Tonix Pharmaceuticals, Inc., Dogwood Therapeutics, Silo Pharma and others.

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 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.

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 Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

From emerging drug candidates to competitive intelligence, the Fibromyalgia Pipeline Report covers it all @ Fibromyalgia Market Drivers and Barriers, and Future Perspectives

Scope of the Fibromyalgia Pipeline Report

• Coverage- Global
• Fibromyalgia Companies- UCB Biopharma SRL, Tonix Pharmaceuticals, Inc., Dogwood Therapeutics, Silo Pharma and others.
• Fibromyalgia Therapies- Paroxetine CR, Lacosamide, Milnacipran, Rotigotine, Duloxetine, Rozanolixizumab, ONO-1110 and others.
• Fibromyalgia Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Fibromyalgia Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Discover what’s next for the Fibromyalgia Treatment landscape in this detailed analysis @ Fibromyalgia Emerging Drugs and Major Players

Table of Contents

1. Introduction
2. Executive Summary
3. Fibromyalgia: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Fibromyalgia– DelveInsight’s Analytical Perspective
7. Late Stage Products (Preregistration)
8. TNX-102 SL: Tonix Pharmaceuticals, Inc.
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. Rozanolixizumab: UCB Biopharma SRL
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. Drug name: Company name
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Fibromyalgia- Unmet Needs
21. Fibromyalgia- Market Drivers and Barriers
22. Appendix

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