Last reviewed · How we verify
TEV-48125 - 1
TEV-48125 - 1 is a Small molecule drug developed by Teva Branded Pharmaceutical Products R&D, Inc.. It is currently in Phase 1 development. Also known as: monoclonal antibody.
TEV-48125 is a calcitonin gene-related peptide antagonist, a type of antibody that targets calcitonin gene-related peptide. It is being studied as a potential treatment for chronic cluster headache and migraine, in comparison to fremanezumab and a placebo.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | TEV-48125 - 1 |
|---|---|
| Also known as | monoclonal antibody |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine (PHASE3)
- Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine (PHASE3)
- A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH) (PHASE2)
- To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125 (PHASE1)
- Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine (PHASE3)
- An Efficacy and Safety Study of Fremanezumab in Adults With Migraine (PHASE3)
- Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine (PHASE3)
- A Study Comparing the Efficacy and Safety of Fremanezumab (TEV-48125) for the Prevention of Chronic Cluster Headache (CCH) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TEV-48125 - 1 CI brief — competitive landscape report
- TEV-48125 - 1 updates RSS · CI watch RSS
- Teva Branded Pharmaceutical Products R&D, Inc. portfolio CI
Frequently asked questions about TEV-48125 - 1
What is TEV-48125 - 1?
Who makes TEV-48125 - 1?
Is TEV-48125 - 1 also known as anything else?
What development phase is TEV-48125 - 1 in?
Related
- Manufacturer: Teva Branded Pharmaceutical Products R&D, Inc. — full pipeline
- Also known as: monoclonal antibody
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing