Fibromyalgia drug pipeline
3 compounds from 3 companies are in active clinical development for fibromyalgia, including 2 at Phase 3 or beyond.
Mechanisms: Small molecule (3)
Pipeline data compiled October 2026 · every fact sourced.
Upcoming readouts & recent results
Topline results anticipated from the pivotal Phase 3 FORWARD trial (NCT07398417) of AXS-14 (esreboxetine) in fibromyalgia; randomized-withdrawal primary endpoint is time to loss of therapeutic response. ↗
FDA approved Tonmya (TNX-102 SL) for fibromyalgia in adults — first new fibromyalgia drug in over 15 years. ↗
Second Phase 3 RESILIENT met its primary endpoint with high significance (p=0.00005); all six key secondaries positive. ↗
Phase 3 RELIEF met its primary endpoint: TNX-102 SL 5.6 mg significantly reduced fibromyalgia pain at Week 14 (p=0.010). ↗
TD-9855 20 mg met the primary endpoint (change in average daily pain score) and FIQ/PGIC secondaries vs placebo in fibromyalgia; 5 mg missed the primary. ↗
Compounds in development (3)
| Compound | Company | Phase | Status | Mechanism |
|---|---|---|---|---|
| TNX-102 SL (cyclobenzaprine HCl sublingual)Fast Track | Tonix Pharmaceuticals Holding Corp. | Approved | Approved | H1 receptor Antagonist |
| AXS-14 (esreboxetine) | Axsome Therapeutics, Inc. | Phase 3 | Recruiting | NET Reuptake inhibitor |
| Ampreloxetine | Theravance Biopharma, Inc. | Discontinued | Discontinued | NET Reuptake inhibitor |
Trials recruiting now
5 registered interventional fibromyalgia trials — none recruiting at present. Browse all on ClinicalTrials.gov →
Frequently asked
- How many drugs are in development for fibromyalgia?
- 3 compounds from 3 companies are in active clinical development for fibromyalgia, including 2 at Phase 3 or beyond.
- Which fibromyalgia drugs are in Phase 3?
- Phase 3 (or later) programs for fibromyalgia include TNX-102 SL (cyclobenzaprine HCl sublingual) and AXS-14 (esreboxetine).
- What are the next fibromyalgia trial readouts?
- Upcoming catalysts include AXS-14 (esreboxetine) (1H 2028).