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AMG 334 Dose 1
AMG 334 Dose 1 is a CGRP receptor antagonist Small molecule drug developed by Amgen. It is currently in Phase 2 development for Migraine prevention. Also known as: Erenumab.
AMG 334 is a fully human monoclonal antibody that targets and inhibits the activity of the calcitonin gene-related peptide (CGRP) receptor.
AMG 334 is a fully human monoclonal antibody that targets and inhibits the activity of the calcitonin gene-related peptide (CGRP) receptor. Used for Migraine prevention.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression). -
Big-pharma sponsor
+3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | AMG 334 Dose 1 |
|---|---|
| Also known as | Erenumab |
| Sponsor | Amgen |
| Drug class | CGRP receptor antagonist |
| Target | CGRP receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 2 |
Mechanism of action
By binding to the CGRP receptor, AMG 334 prevents the action of CGRP, a neuropeptide involved in the transmission of pain signals. This mechanism of action is thought to be beneficial in the treatment of migraine. The exact molecular target of AMG 334 is the CGRP receptor, which is a G protein-coupled receptor.
Approved indications
- Migraine prevention
Common side effects
- Injection site reactions
- Nausea
- Headache
Key clinical trials
- Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (PHASE3)
- Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine (PHASE3)
- AMG 334 20160172 Pediatric Migraine PK Study. (PHASE1)
- Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention (PHASE2)
- A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention (PHASE2)
- Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention (PHASE3)
- To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients (PHASE1)
- Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan (PHASE1)
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:
- AMG 334 Dose 1 CI brief — competitive landscape report
- AMG 334 Dose 1 updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about AMG 334 Dose 1
What is AMG 334 Dose 1?
How does AMG 334 Dose 1 work?
What is AMG 334 Dose 1 used for?
Who makes AMG 334 Dose 1?
Is AMG 334 Dose 1 also known as anything else?
What drug class is AMG 334 Dose 1 in?
What development phase is AMG 334 Dose 1 in?
What are the side effects of AMG 334 Dose 1?
What does AMG 334 Dose 1 target?
Related
- Drug class: All CGRP receptor antagonist drugs
- Target: All drugs targeting CGRP receptor
- Manufacturer: Amgen — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Migraine prevention
- Also known as: Erenumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing