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Amg dose administration group
Amg dose administration group is a Small molecule drug developed by J2H Biotech. It is currently in Phase 1 development.
AMG 531 is a treatment used in clinical studies for conditions such as Myelodysplastic Syndromes and Thrombocytopenia, and is administered via injection. AMG 531 is a biological vaccine that induces an immune response, according to its mechanism of action.
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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 | Amg dose administration 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)
- A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome (PHASE2)
- Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria (PHASE2)
- Study to Evaluate the Safety/Tolerability, PK and PD After Intravenous DWJ1521 Administration in Healthy Volunteers (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 dose administration group CI brief — competitive landscape report
- Amg dose administration group updates RSS · CI watch RSS
- J2H Biotech portfolio CI
Frequently asked questions about Amg dose administration group
What is Amg dose administration group?
Who makes Amg dose administration group?
What development phase is Amg dose administration group in?
Related
- Manufacturer: J2H Biotech — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing