pharma · Fibromyalgia · Primary Fibromyalgia · TNXP
Tonix Pharmaceuticals is a pharma organization headquartered in Berkeley Heights, USA. It trades on NYSE under ticker TNXP. Primary therapeutic focus areas include Fibromyalgia, Primary Fibromyalgia, PTSD, Acute Stress R
Phase 3 · small molecule · Fibromyalgia
TNX-102 SL Tablet, 2.8 mg is a small-molecule therapeutic candidate developed by Tonix Pharmaceuticals Holding for the treatment of fibromyalgia. The program, identified by internal code TNX-CY-F301, is currently in Phase 3 clinical development. As of February 7, 2025, the program status is listed as completed, though
Internal code TNX-CY-F301
TNX-102 SL Tablet, 2.8 mg is a small-molecule therapeutic candidate developed by Tonix Pharmaceuticals Holding for the treatment of fibromyalgia. The program, identified by internal code TNX-CY-F301, is currently in Phase 3 clinical development. As of February 7, 2025, the program status is listed as completed, though specific details regarding trial outcomes or regulatory next steps are not yet disclosed.
Fibromyalgia remains a significant unmet medical need characterized by widespread musculoskeletal pain, fatigue, and sleep disturbance. TNX-102 SL represents Tonix's focused therapeutic strategy in this indication, with the 2.8 mg formulation as the lead candidate. The program is supported by multiple clinical trials, including the primary trial NCT02436096 and additional studies across multiple geographies, suggesting a comprehensive development and regulatory strategy.
The competitive landscape for fibromyalgia therapeutics includes established agents such as Xyrem (sodium oxybate) from Jazz Pharmaceuticals and emerging candidates including AXS-14 (esreboxetine) from Axsome Therapeutics in Phase 3. Tonix is also developing a 5.6 mg formulation variant of TNX-102 SL, indicating dose optimization efforts. The completion of Phase 3 development positions TNX-102 SL for potential regulatory submission, though the specific timing and jurisdiction for such filings remain undisclosed.
Fibromyalgia affects millions of patients globally and remains inadequately treated despite the availability of several FDA-approved therapies. The condition is characterized by chronic widespread pain, cognitive dysfunction, sleep disturbance, and fatigue, significantly impairing quality of life and work productivity. Current treatment options, including pregabalin, duloxetine, and milnacipran, demonstrate variable efficacy and tolerability, creating substantial unmet medical need for novel therapeutic approaches.
TNX-102 SL's advancement to completed Phase 3 status reflects meaningful clinical progress in addressing this market opportunity. The fibromyalgia therapeutic market represents a significant commercial opportunity, with multiple competing programs in late-stage development. Tonix's dual-formulation strategy (2.8 mg and 5.6 mg) suggests differentiation through dose optimization, potentially addressing efficacy-tolerability tradeoffs that limit current therapies.
The program's competitive positioning is notable within a crowded field. Jazz Pharmaceuticals' Xyrem (sodium oxybate) holds market leadership, while Axsome's AXS-14 represents a direct Phase 3 competitor. The approval of TRAPEZIUS by The George Institute demonstrates continued regulatory acceptance of new fibromyalgia agents. TNX-102 SL's completion of Phase 3 development positions it as a near-term potential market entrant, with significant commercial implications for Tonix if regulatory approval is achieved. The patient population—predominantly female, middle-aged to older adults—represents a substantial addressable market with high treatment burden and willingness to adopt new therapies demonstrating improved efficacy or tolerability profiles.
TNX-102 SL Tablet, 2.8 mg is a small-molecule therapeutic candidate. The specific mechanism of action, molecular target, and route of administration are not yet disclosed in available sources. The drug is formulated as a tablet for oral administration, based on the formulation designation 'SL' (sublingual or sustained-release variant).
Also known as: fibromyalgia syndrome
A chronic disorder of unknown etiology characterized by pain, stiffness, and tenderness in the muscles of neck, shoulders, back, hips, arms, and legs. Other signs and symptoms include headaches, fatigue, sleep disturbances, and painful menstruation.
ClinicalTrials.gov lists 67 registered studies for Fibromyalgia Syndrome (AACT aggregate).
Phase breakdown: NA (53), PHASE2 (8), PHASE3 (4), PHASE4 (2)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0005546), Orphanet — fibromyalgia, NCT00222274, NCT00401830, NCT00436033, NCT00447083, NCT00464737, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Phase 3 initiation
TNX-102 SL entered Phase 3 clinical development for fibromyalgia.
Phase 3 completion
Phase 3 clinical development program for TNX-102 SL Tablet, 2.8 mg completed as of February 7, 2025.
Regulatory submission expected
Timing and jurisdiction for regulatory filing not yet disclosed.
The fibromyalgia therapeutic landscape includes both established and emerging competitors. Jazz Pharmaceuticals' Xyrem (sodium oxybate) represents the market-leading approved therapy, with extensive clinical evidence and established market presence. TRAPEZIUS, approved by The George Institute, demonstrates continued regulatory acceptance of novel fibromyalgia agents and represents recent competitive entry.
In late-stage development, Axsome Therapeutics' AXS-14 (esreboxetine) represents the most direct Phase 3 competitor to TNX-102 SL. Both programs are pursuing similar timelines toward potential regulatory approval. Tonix's dual-formulation strategy—with both 2.8 mg and 5.6 mg variants in Phase 3—suggests a differentiated approach focused on dose optimization, potentially addressing efficacy-tolerability tradeoffs that limit competitors.
United Therapeutics Europe Ltd's erenumab is also noted in Phase 3 development for fibromyalgia, representing a distinct mechanistic approach (monoclonal antibody) compared to TNX-102 SL's small-molecule platform. The competitive environment reflects growing pharmaceutical interest in fibromyalgia, driven by substantial unmet medical need and a large patient population. TNX-102 SL's completion of Phase 3 positions it as a near-term potential market entrant, though regulatory approval timing and commercial success will depend on efficacy, safety, and tolerability data relative to existing and emerging competitors.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| TRAPEZIUS | The George Institute | small_molecule | approved |
| TNX-102 SL Tablet 2.8 mg | Tonix Pharmaceuticals Holding | small_molecule | phase_3 |
| AXS-14 (Esreboxetine) | Axsome Therapeutics | small_molecule | phase_3 |
| TNX-102 SL 2.8mg | Tonix Pharmaceuticals Holding | small_molecule | phase_3 |
| TNX-102 SL | Tonix Pharmaceuticals Holding | small_molecule | phase_3 |
| TNX-102 SL Tablet, 2.8 mg | Tonix Pharmaceuticals Holding | small_molecule | phase_3 |
| TNX-102 SL Tablet, 5.6 mg | Tonix Pharmaceuticals Holding | small_molecule | phase_3 |
| Erenumab | United Therapeutics Europe Ltd | small_molecule | phase_3 |
| placebo | Jazz Pharmaceuticals Ireland Limited | small_molecule | phase_3 |
| Xyrem® | Jazz Pharmaceuticals Ireland Limited | small_molecule | phase_3 |
| Sodium Oxybate | Jazz Pharmaceuticals Ireland Limited | small_molecule | phase_3 |
| PREGABALIN | — | Voltage-gated calcium channel modulator | Approved |
| MILNACIPRAN HYDROCHLORIDE | — | Serotonin transporter inhibitor | Approved |
| LEVOMILNACIPRAN HYDROCHLORIDE | — | Norepinephrine transporter inhibitor | Approved |
| DULOXETINE HYDROCHLORIDE | — | Serotonin transporter inhibitor | Approved |
| TRAMADOL | — | Mu opioid receptor agonist | Phase 3 |
| SOMATROPIN | — | Growth hormone receptor agonist | Phase 3 |
| REBOXETINE | — | Norepinephrine transporter inhibitor | Phase 3 |
| OXYBATE | — | GABA-B receptor agonist | Phase 3 |
| MIROGABALIN | — | Voltage-gated calcium channel alpha2/delta subunit 2 modulator | Phase 3 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
TNX-102 SL Tablet, 2.8 mg is currently in Phase 3 clinical development and has not yet received regulatory approval from the FDA, EMA, PMDA (Japan), or NMPA (China).
The program's Phase 3 completion as of February 7, 2025 suggests imminent regulatory activity, though specific filing timelines, jurisdictions, and regulatory pathways remain undisclosed.
TNX-102 SL Tablet, 2.8 mg is a small-molecule therapeutic candidate in development for the treatment of fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain, fatigue, and sleep disturbance.
No, TNX-102 SL Tablet, 2.8 mg has not yet received FDA approval. As of February 7, 2025, the program has completed Phase 3 clinical development, but regulatory submission and approval status remain undisclosed.
TNX-102 SL is developed and sponsored by Tonix Pharmaceuticals Holding. No manufacturing partners or licensing agreements are disclosed.
The specific mechanism of action for TNX-102 SL is not yet disclosed in available sources.
The molecular target of TNX-102 SL is not yet disclosed.
TNX-102 SL is supported by multiple clinical trials, including the primary trial NCT02436096 and seven additional registered trials (NCT03770624, NCT05560360, NCT05767892, NCT06348498, NCT06385158, NCT06908642, NCT07189949). Detailed trial results are not yet reported.
TNX-102 SL Tablet, 2.8 mg is in Phase 3 clinical development. The Phase 3 program was completed as of February 7, 2025.
Both TNX-102 SL and Xyrem (sodium oxybate) are in development or approved for fibromyalgia treatment. Xyrem is an established approved therapy, while TNX-102 SL is in Phase 3 development. Comparative efficacy and safety data are not yet disclosed.
Key competitors include Xyrem (sodium oxybate, approved) from Jazz Pharmaceuticals, TRAPEZIUS (approved) from The George Institute, and AXS-14 (esreboxetine, Phase 3) from Axsome Therapeutics. Erenumab from United Therapeutics Europe Ltd is also in Phase 3 development for fibromyalgia.
Yes, Tonix is developing TNX-102 SL in multiple formulations, including a 2.8 mg tablet (lead candidate) and a 5.6 mg tablet, both in Phase 3 development. This dual-formulation strategy suggests dose optimization efforts.
Regulatory approval timing is not yet disclosed. Phase 3 completion as of February 7, 2025 suggests potential regulatory submission in the near term, but specific timelines remain undisclosed.
TNX-102 SL is formulated as a tablet for oral administration. The specific route (sublingual, sustained-release, or standard oral) is not yet explicitly disclosed.
Breakthrough therapy designation status for TNX-102 SL is not yet disclosed.
Projected peak sales figures for TNX-102 SL are not yet disclosed.
Based on available information, TNX-102 SL development is focused on fibromyalgia. Development in other indications is not disclosed.
Patent status and expiration dates for TNX-102 SL are not yet disclosed.
TNX-102 SL Tablet, 2.8mg → Drug → Target → Indication → Company → Trials → Competitors
Development Trajectory: TNX-102 SL's completion of Phase 3 development as of February 7, 2025 represents a significant milestone for Tonix Pharmaceuticals. The program has progressed through a comprehensive clinical trial portfolio spanning multiple geographies, with seven distinct clinical trials registered on ClinicalTrials.gov. This breadth of clinical activity suggests a robust development strategy and potential preparation for multi-regional regulatory submissions.
Competitive Positioning: TNX-102 SL enters a competitive fibromyalgia market with established players (Xyrem, TRAPEZIUS) and near-term competitors (AXS-14). Tonix's dual-formulation approach (2.8 mg and 5.6 mg variants) may provide differentiation through optimized dosing, addressing a key limitation of current therapies. However, the program faces significant competitive pressure from Axsome's AXS-14, which is also in Phase 3 and may reach regulatory decision points on similar timelines.
Regulatory Catalysts: The immediate catalyst for TNX-102 SL is regulatory submission and FDA review. Timing for New Drug Application (NDA) filing is not yet disclosed, but Phase 3 completion typically precedes regulatory submission within 6-12 months. Potential breakthrough therapy designation or priority review status could accelerate timelines, though such designations are not yet disclosed.
Commercial Implications: Peak sales projections are not yet disclosed, limiting assessment of commercial potential. However, the fibromyalgia market represents a substantial opportunity given the large patient population and inadequate current treatment options. Successful approval and market entry could generate meaningful revenue, particularly if TNX-102 SL demonstrates superior efficacy or tolerability compared to existing therapies.
Key Uncertainties: Critical information gaps include mechanism of action, specific efficacy and safety data from Phase 3 trials, regulatory submission timelines, and commercial strategy. These details will be essential for comprehensive competitive and commercial assessment upon disclosure.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.