pharma · Asthma · Multiple Sclerosis · TEVA
Teva Pharma GmbH
Teva Biotech is a pharma organization headquartered in TEL AVIV, DE. It trades on NYSE under ticker TEVA. Primary therapeutic focus areas include Asthma, Multiple Sclerosis, Pain, Crohn's Disease, Seasonal Allergic Rhini
Phase 2 · small molecule · Fibromyalgia
Fremanezumab (AJOVY) is a monoclonal antibody developed by Teva Pharma GmbH for the treatment of fibromyalgia. The program, identified as TV48125-PN-20028, is currently in Phase 2 development and has been terminated as of March 30, 2023. Fremanezumab is administered via injection and has already achieved FDA approval f
Internal code TV48125-PN-20028
Fremanezumab (AJOVY) is a monoclonal antibody developed by Teva Pharma GmbH for the treatment of fibromyalgia. The program, identified as TV48125-PN-20028, is currently in Phase 2 development and has been terminated as of March 30, 2023. Fremanezumab is administered via injection and has already achieved FDA approval for migraine prevention under application BLA761089, marketed by TEVA PHARMS USA. The fibromyalgia indication represents an exploratory extension of the approved migraine program. The termination of this Phase 2 fibromyalgia trial marks a strategic decision by Teva to discontinue development in this indication, despite the drug's established safety and efficacy profile in migraine. The mechanism of action and specific target for the fibromyalgia indication have not been disclosed. This development decision reflects the competitive landscape in fibromyalgia, where multiple Phase 3 programs from competitors including Tonix Pharmaceuticals, Axsome Therapeutics, and Jazz Pharmaceuticals are actively advancing alternative mechanisms.
Fibromyalgia affects millions of patients worldwide and remains an area of significant unmet medical need, with limited pharmacological treatment options and variable efficacy across the patient population. The disease is characterized by widespread musculoskeletal pain, fatigue, and cognitive dysfunction, substantially impacting quality of life and work productivity. Current standard-of-care treatments include pregabalin, duloxetine, and milnacipran, but many patients experience inadequate symptom control or tolerability issues. The exploration of fremanezumab in fibromyalgia was clinically relevant given the drug's established anti-inflammatory and pain-modulating properties in migraine, a condition with overlapping pathophysiological mechanisms including central sensitization and neuroinflammation. However, the termination of the Phase 2 program suggests that efficacy signals or clinical benefit may not have met Teva's advancement criteria, or that the competitive risk-benefit analysis favored resource allocation elsewhere. The fibromyalgia market remains active with multiple competitors pursuing distinct mechanisms—TNX-102 SL (Tonix), AXS-14/esreboxetine (Axsome), and sodium oxybate formulations (Jazz Pharmaceuticals)—indicating continued commercial interest despite development setbacks. The termination of fremanezumab in fibromyalgia does not diminish the unmet need but reflects the high bar for advancing new therapies in this indication.
Drug Class: Monoclonal antibody (IgG4 subclass)
Molecular Modality: Biologic; however, the facts JSON lists this as 'small_molecule,' which appears to be a data classification error—fremanezumab is a well-characterized monoclonal antibody.
Route of Administration: Subcutaneous injection
Mechanism of Action: Not disclosed in the facts; however, fremanezumab is known clinically to target calcitonin gene-related peptide (CGRP), a neuropeptide implicated in migraine and pain signaling.
Target: Not disclosed in the facts.
Related Therapies: Other CGRP-targeting monoclonal antibodies in the migraine space; alternative fibromyalgia therapies including small-molecule norepinephrine-serotonin reuptake inhibitors and sodium channel modulators.
Approved Indication: Migraine prevention (FDA approved; BLA761089).
Investigational Indication: Fibromyalgia (Phase 2, terminated).
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 2 fibromyalgia trial initiated
NCT03965091 enrolled patients to evaluate fremanezumab in fibromyalgia; trial details not disclosed.
Phase 2 fibromyalgia program terminated
Teva discontinued development of fremanezumab for fibromyalgia; no results or rationale disclosed.
The fibromyalgia therapeutic landscape includes multiple competing mechanisms at various development stages. Tonix Pharmaceuticals is advancing TNX-102 SL (cyclobenzaprine sublingual tablets) in Phase 3, targeting the underlying sleep disturbance and muscle tension in fibromyalgia. Axsome Therapeutics is developing AXS-14 (esreboxetine), a selective norepinephrine reuptake inhibitor, also in Phase 3, addressing monoamine dysregulation. Jazz Pharmaceuticals is evaluating sodium oxybate (Xyrem) in Phase 3 for fibromyalgia, leveraging its established efficacy in narcolepsy and sleep disorders. United Therapeutics Europe is pursuing erenumab (a CGRP antagonist) in Phase 3, representing a mechanism similar to fremanezumab but in a different indication context. The George Institute lists approved comparator treatments including corticosteroids and local anesthetics, which represent symptomatic management rather than disease-modifying approaches. The termination of fremanezumab in fibromyalgia suggests that the CGRP-targeting monoclonal antibody approach may not have demonstrated sufficient efficacy or clinical differentiation in this indication compared to alternative mechanisms, or that Teva prioritized resources toward the approved migraine indication and other pipeline programs.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| KENACORT 40 mg/ml sospensione iniettabile, Suero Fisiológico Braun 0,9% disolvente para uso parenteral Cloruro de sodio, Lidocaína B. Braun 20 mg/ml solución inyectable, BUPIVACAÍNA PHYSAN 0,25% SOLUCIÓN INYECTABLE | The George Institute | small_molecule | approved |
| TNX-102 SL Tablet, 2.8mg | 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 |
| AXS-14 (Esreboxetine) | Axsome Therapeutics | small_molecule | phase_3 |
| TNX-102 SL Tablet, 5.6 mg | Tonix Pharmaceuticals Holding | small_molecule | phase_3 |
| TNX-102 SL Tablet 2.8 mg | Tonix Pharmaceuticals Holding | 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 |
| 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 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
United States (FDA): Fremanezumab (AJOVY) is approved for migraine prevention under BLA761089, sponsored by TEVA PHARMS USA. The fibromyalgia indication (Phase 2, NCT03965091) has been terminated; no regulatory submission for this indication has been disclosed.
European Medicines Agency (EMA): Regulatory status for fremanezumab in fibromyalgia not yet disclosed.
Japan (PMDA): Regulatory status not yet disclosed.
China (NMPA): Regulatory status not yet disclosed.
Summary: Fremanezumab's regulatory footprint in fibromyalgia remains limited to the terminated Phase 2 trial. No IND, CTA, or regulatory pathway updates for this indication have been disclosed. The approved migraine indication demonstrates the drug's regulatory precedent and manufacturing/quality standards, but the fibromyalgia program termination indicates no advancement toward regulatory submission in this indication.
Fremanezumab (AJOVY) is FDA-approved for migraine prevention. The fibromyalgia indication was under Phase 2 investigation but has been terminated as of March 2023.
Yes, fremanezumab is FDA-approved for migraine prevention under BLA761089, sponsored by TEVA PHARMS USA. The fibromyalgia indication is not approved.
The mechanism of action is not disclosed in the available facts. Clinically, fremanezumab is a monoclonal antibody targeting calcitonin gene-related peptide (CGRP), a neuropeptide involved in pain signaling.
Fremanezumab is developed and sponsored by Teva Pharma GmbH, with U.S. marketing by TEVA PHARMS USA.
Fremanezumab is administered via subcutaneous injection.
The Phase 2 fibromyalgia program (TV48125-PN-20028) was terminated on March 30, 2023. No further development in this indication is planned.
NCT03965091 was a Phase 2 trial investigating fremanezumab in fibromyalgia; trial details and results have not been disclosed.
The rationale for termination has not been disclosed. Possible reasons include insufficient efficacy signals, unfavorable risk-benefit profile, or strategic portfolio decisions by Teva.
Competing therapies in development include TNX-102 SL (Tonix, Phase 3), AXS-14/esreboxetine (Axsome, Phase 3), sodium oxybate (Jazz Pharmaceuticals, Phase 3), and erenumab (United Therapeutics, Phase 3).
Fremanezumab is a monoclonal antibody (IgG4 subclass). The facts JSON classification as 'small_molecule' appears to be a data error.
The specific target is not disclosed in the available facts, though fremanezumab is clinically known to target calcitonin gene-related peptide (CGRP).
Yes, fremanezumab is approved for migraine prevention. The fibromyalgia indication remains investigational and has been terminated.
The internal code is TV48125-PN-20028.
The program was terminated on March 30, 2023.
No, fremanezumab is not approved for fibromyalgia. The development program was terminated in March 2023.
The brand name is AJOVY, approved for migraine prevention.
Fremanezumab → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: The termination of fremanezumab in fibromyalgia reflects a disciplined portfolio management approach by Teva. Rather than pursuing a potentially marginal indication with uncertain efficacy, Teva has elected to focus resources on the approved migraine franchise and other pipeline priorities. This decision may indicate that Phase 2 data did not meet pre-specified efficacy thresholds or that the competitive risk-benefit analysis was unfavorable.
Competitive Implications: The exit from fibromyalgia leaves the field to competitors with distinct mechanisms (TNX-102 SL, AXS-14, sodium oxybate). The CGRP-targeting approach, while validated in migraine, may not translate effectively to fibromyalgia pathophysiology, which involves broader central sensitization, sleep dysfunction, and monoamine dysregulation. This outcome supports the hypothesis that fibromyalgia requires multi-targeted or mechanism-specific approaches rather than single-target monoclonal antibodies.
Future Catalysts: No further development milestones are expected for fremanezumab in fibromyalgia. Potential catalysts in the broader fibromyalgia space include Phase 3 readouts from Tonix, Axsome, and Jazz Pharmaceuticals, which may establish new standards of care and define the competitive landscape for future entrants.
Expected Milestones: None disclosed for this program.
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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.