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Pimicotinib(ABSK021)
Pimicotinib(ABSK021) is a HER2 tyrosine kinase inhibitor Small molecule drug developed by Abbisko Therapeutics Co, Ltd. It is currently in Phase 3 development for HER2-positive breast cancer, HER2-positive gastric cancer.
Pimicotinib is a tyrosine kinase inhibitor that targets HER2 (human epidermal growth factor receptor 2) to inhibit cancer cell growth and proliferation.
Pimicotinib (ABSK021) is a small molecule being studied in clinical trials for various conditions, including chronic graft versus host disease (cGvHD), advanced pancreatic cancer, and tenosynovial giant cell tumor. The exact mechanism of action of Pimicotinib is not specified in the available information, but it is being investigated in a Phase II clinical trial for the treatment of cGvHD.
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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 | Pimicotinib(ABSK021) |
|---|---|
| Sponsor | Abbisko Therapeutics Co, Ltd |
| Drug class | HER2 tyrosine kinase inhibitor |
| Target | HER2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pimicotinib selectively inhibits HER2 tyrosine kinase activity, blocking downstream signaling pathways that drive cell proliferation in HER2-positive cancers. By preventing HER2 autophosphorylation and activation of growth-promoting pathways, the drug induces cell cycle arrest and apoptosis in HER2-dependent tumor cells.
Approved indications
- HER2-positive breast cancer
- HER2-positive gastric cancer
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Rash
- Vomiting
Key clinical trials
- Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER) (PHASE3)
- A Mass Balance Study of [14C]ABSK021 (PHASE1)
- A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD) (PHASE2)
- A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer (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:
- Pimicotinib(ABSK021) CI brief — competitive landscape report
- Pimicotinib(ABSK021) updates RSS · CI watch RSS
- Abbisko Therapeutics Co, Ltd portfolio CI
Frequently asked questions about Pimicotinib(ABSK021)
What is Pimicotinib(ABSK021)?
How does Pimicotinib(ABSK021) work?
What is Pimicotinib(ABSK021) used for?
Who makes Pimicotinib(ABSK021)?
What drug class is Pimicotinib(ABSK021) in?
What development phase is Pimicotinib(ABSK021) in?
What are the side effects of Pimicotinib(ABSK021)?
What does Pimicotinib(ABSK021) target?
Related
- Drug class: All HER2 tyrosine kinase inhibitor drugs
- Target: All drugs targeting HER2
- Manufacturer: Abbisko Therapeutics Co, Ltd — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for HER2-positive breast cancer
- Indication: Drugs for HER2-positive gastric cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing