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JAB-21822
JAB-21822 is a FGFR inhibitor Small molecule drug developed by Allist Pharmaceuticals, Inc.. It is currently in Phase 3 development for FGFR-driven solid tumors (Phase 3 development). Also known as: glecirasib, Glecirasib.
JAB-21822 is a selective inhibitor of fibroblast growth factor receptor (FGFR) signaling that blocks aberrant growth signals in cells dependent on FGFR activation.
JAB-21822 is a selective inhibitor of fibroblast growth factor receptor (FGFR) signaling that blocks aberrant growth signals in cells dependent on FGFR activation. Used for FGFR-driven 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-21822 |
|---|---|
| Also known as | glecirasib, Glecirasib |
| 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-21822 targets FGFR pathways implicated in various cancers and fibrotic diseases. By inhibiting FGFR kinase activity, the drug suppresses downstream signaling cascades that drive cell proliferation and survival in FGFR-dependent tumors and tissues. This mechanism is particularly relevant in cancers with FGFR amplifications, fusions, or mutations.
Approved indications
- FGFR-driven solid tumors (Phase 3 development)
Common side effects
- Hyperphosphatemia
- Diarrhea
- Fatigue
- Nausea
Key clinical trials
- JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation (PHASE1, PHASE2)
- A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China (PHASE1, PHASE2)
- A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation. (PHASE2)
- Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated NSCLC (PHASE1, PHASE2)
- JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation (PHASE1, PHASE2)
- JAB-21822 Combined With Chemotherapy and Bevacizumab in Second-line KRAS G12C CRC (PHASE1)
- A Food Effect Study of JAB-21822 in Healthy Subjects (PHASE1)
- Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation (PHASE1, PHASE2)
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-21822 CI brief — competitive landscape report
- JAB-21822 updates RSS · CI watch RSS
- Allist Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about JAB-21822
What is JAB-21822?
How does JAB-21822 work?
What is JAB-21822 used for?
Who makes JAB-21822?
Is JAB-21822 also known as anything else?
What drug class is JAB-21822 in?
What development phase is JAB-21822 in?
What are the side effects of JAB-21822?
What does JAB-21822 target?
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-driven solid tumors (Phase 3 development)
- Also known as: glecirasib, Glecirasib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing