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Gecacitinib
Gecacitinib is a Small molecule drug developed by Nanfang Hospital, Southern Medical University. It is currently in Phase 2 development. Also known as: Jaktinib.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Gecacitinib |
|---|---|
| Also known as | Jaktinib |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Gecacitinib in the Treatment of Steroid-Refractory/Dependent Chronic Graf Versus Host Disease (cGVHD). (PHASE1, PHASE2)
- Gecacitinib Pre-, During- and Post-HSCT for Patients With Primary or Secondary Myelofibrosis (PHASE2)
- A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV (NA)
- Efficacy and Safety of Gecacitinib Hydrochloride in Prophylaxis Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelofibrosis (NA)
- Clinical Trail to Evaluate the Effect of Long-term Treatment With Gecacitinib on Myelofibrosis and Gene Mutation Levels
- Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer (PHASE1, PHASE2)
- Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma (PHASE1, PHASE2)
- Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer (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:
- Gecacitinib CI brief — competitive landscape report
- Gecacitinib updates RSS · CI watch RSS
- Nanfang Hospital, Southern Medical University portfolio CI
Frequently asked questions about Gecacitinib
What is Gecacitinib?
Who makes Gecacitinib?
Is Gecacitinib also known as anything else?
What development phase is Gecacitinib in?
Related
- Manufacturer: Nanfang Hospital, Southern Medical University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Jaktinib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing