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Single administration Amg dose Group
Single administration Amg dose Group is a Small molecule drug developed by J2H Biotech. It is currently in Phase 1 development.
AMG 334, also known as Erenumab, is a vaccine component that induces an immune response. It has been studied in clinical trials for various conditions, including Migraine, Atopic Dermatitis, Heart Failure, Non-alcoholic Steatohepatitis, and KRAS p.G12C Mutant Advanced Solid Tumors.
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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 | Single administration Amg dose Group |
|---|---|
| Sponsor | J2H Biotech |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD) (PHASE1)
- A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) (PHASE1, PHASE2)
- A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants (PHASE1)
- Investigate Safety, Tolerability, PK/PK of J2H 1702 in Healthy Males (PHASE1)
- Investigate Safety, Tolerability, PK/PD of J2H-1702 in Healthy Females (PHASE1)
- Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function (PHASE1)
- To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients (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:
- Single administration Amg dose Group CI brief — competitive landscape report
- Single administration Amg dose Group updates RSS · CI watch RSS
- J2H Biotech portfolio CI
Frequently asked questions about Single administration Amg dose Group
What is Single administration Amg dose Group?
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What development phase is Single administration Amg dose Group in?
Related
- Manufacturer: J2H Biotech — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing