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ABX464 Repeated dose
ABX464 Repeated dose is a Small molecule Small molecule drug developed by Abivax S.A.. It is currently in Phase 1 development for Treatments for autoimmune diseases.
ABX464 is a small molecule antagonist of RARγ
ABX464 is a small molecule that modulates the cap binding complex, classified as a modulator. It was studied in a clinical trial (NCT02731885) involving healthy volunteers to investigate its pharmacokinetic parameters after single and repeated doses.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | ABX464 Repeated dose |
|---|---|
| Sponsor | Abivax S.A. |
| Drug class | Small molecule |
| Target | RARγ |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 1 |
Mechanism of action
ABX464 acts by binding to the retinoic acid receptor gamma (RARγ), thereby modulating the immune response and reducing inflammation.
Approved indications
- Treatments for autoimmune diseases
Common side effects
- Nausea
- Headache
- Diarrhea
Key clinical trials
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:
- ABX464 Repeated dose CI brief — competitive landscape report
- ABX464 Repeated dose updates RSS · CI watch RSS
- Abivax S.A. portfolio CI
Frequently asked questions about ABX464 Repeated dose
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Related
- Drug class: All Small molecule drugs
- Target: All drugs targeting RARγ
- Manufacturer: Abivax S.A. — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Treatments for autoimmune diseases
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing