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ALD403 (Eptinezumab)
ALD403 (Eptinezumab) is a CGRP monoclonal antibody Biologic drug developed by Alder Biopharmaceuticals, Inc.. It is currently in Phase 3 development for Episodic migraine prevention, Chronic migraine prevention. Also known as: Eptinezumab-jjmr, Vyepti.
Eptinezumab is a monoclonal antibody that binds to and blocks calcitonin gene-related peptide (CGRP), a neuropeptide involved in migraine pathogenesis.
Eptinezumab is a monoclonal antibody that binds to and blocks calcitonin gene-related peptide (CGRP), a neuropeptide involved in migraine pathogenesis. Used for Episodic migraine prevention, Chronic migraine prevention.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | ALD403 (Eptinezumab) |
|---|---|
| Also known as | Eptinezumab-jjmr, Vyepti |
| Sponsor | Alder Biopharmaceuticals, Inc. |
| Drug class | CGRP monoclonal antibody |
| Target | CGRP (Calcitonin Gene-Related Peptide) |
| Modality | Biologic |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
CGRP is released during migraine attacks and contributes to pain signaling and neuroinflammation. By neutralizing circulating CGRP, eptinezumab prevents its interaction with CGRP receptors on sensory neurons and blood vessels, thereby reducing migraine frequency and severity. This mechanism is distinct from traditional migraine treatments and represents a targeted approach to migraine prevention.
Approved indications
- Episodic migraine prevention
- Chronic migraine prevention
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
- Injection site reactions
- Antibody formation
Key clinical trials
- Migraine Induction Properties of PACAP-38 After Eptinezumab in Migraine Without Aura Patients. (NA)
- Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PHASE3)
- A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PHASE3)
- An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine (PHASE3)
- A Multicenter Assessment of ALD403 in Chronic Migraine (PHASE2)
- Safety, Efficacy and Pharmacokinetics of ALD403 (PHASE1)
- Safety Tolerability and Pharmacokinetics of ALD403 (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:
- ALD403 (Eptinezumab) CI brief — competitive landscape report
- ALD403 (Eptinezumab) updates RSS · CI watch RSS
- Alder Biopharmaceuticals, Inc. portfolio CI
Frequently asked questions about ALD403 (Eptinezumab)
What is ALD403 (Eptinezumab)?
How does ALD403 (Eptinezumab) work?
What is ALD403 (Eptinezumab) used for?
Who makes ALD403 (Eptinezumab)?
Is ALD403 (Eptinezumab) also known as anything else?
What drug class is ALD403 (Eptinezumab) in?
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What are the side effects of ALD403 (Eptinezumab)?
What does ALD403 (Eptinezumab) target?
Related
- Drug class: All CGRP monoclonal antibody drugs
- Target: All drugs targeting CGRP (Calcitonin Gene-Related Peptide)
- Manufacturer: Alder Biopharmaceuticals, Inc. — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Episodic migraine prevention
- Indication: Drugs for Chronic migraine prevention
- Also known as: Eptinezumab-jjmr, Vyepti
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing