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JAB-3312
JAB-3312 is a FGFR inhibitor Small molecule drug developed by Allist Pharmaceuticals, Inc.. It is currently in Phase 3 development for FGFR-altered solid tumors (Phase 3 development).
JAB-3312 is a selective inhibitor of fibroblast growth factor receptor (FGFR) signaling.
JAB-3312 is a selective inhibitor of fibroblast growth factor receptor (FGFR) signaling. Used for FGFR-altered solid tumors (Phase 3 development).
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | JAB-3312 |
|---|---|
| Sponsor | Allist Pharmaceuticals, Inc. |
| Drug class | FGFR inhibitor |
| Target | FGFR (Fibroblast Growth Factor Receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
JAB-3312 targets FGFR pathways that are dysregulated in certain cancers and fibrotic diseases. By inhibiting FGFR activity, the drug aims to suppress aberrant cell proliferation and reduce pathological fibrosis. This mechanism is particularly relevant in tumors with FGFR alterations and in conditions characterized by excessive fibroblast activation.
Approved indications
- FGFR-altered solid tumors (Phase 3 development)
Common side effects
- Hyperphosphatemia
- Diarrhea
- Fatigue
- Nausea
Key clinical trials
- A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors (PHASE1)
- A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China (PHASE1)
- JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors (PHASE1, PHASE2)
- Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation (PHASE1, PHASE2)
- JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation (PHASE3)
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:
- JAB-3312 CI brief — competitive landscape report
- JAB-3312 updates RSS · CI watch RSS
- Allist Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about JAB-3312
What is JAB-3312?
How does JAB-3312 work?
What is JAB-3312 used for?
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Related
- Drug class: All FGFR inhibitor drugs
- Target: All drugs targeting FGFR (Fibroblast Growth Factor Receptor)
- Manufacturer: Allist Pharmaceuticals, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for FGFR-altered solid tumors (Phase 3 development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing