Last reviewed 2026-05-31 · How we verify

[14C]-Jaktinib

Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 1 active Small molecule ✓ Verified May 2026

[14C]-Jaktinib is a Small molecule drug developed by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. It is currently in Phase 1 development.

Jaktinib is a small molecule. Its mechanism of action is not specified in the provided facts, but it is listed as a small molecule on ChEMBL.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	[14C]-Jaktinib
Sponsor	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

[14C]-Jaktinib CI brief — competitive landscape report
[14C]-Jaktinib updates RSS · CI watch RSS
Suzhou Zelgen Biopharmaceuticals Co.,Ltd portfolio CI

Frequently asked questions about [14C]-Jaktinib

What is [14C]-Jaktinib?

[14C]-Jaktinib is a Small molecule drug developed by Suzhou Zelgen Biopharmaceuticals Co.,Ltd.

Who makes [14C]-Jaktinib?

[14C]-Jaktinib is developed by Suzhou Zelgen Biopharmaceuticals Co.,Ltd (see full Suzhou Zelgen Biopharmaceuticals Co.,Ltd pipeline at /company/suzhou-zelgen-biopharmaceuticals-co-ltd).

What development phase is [14C]-Jaktinib in?

[14C]-Jaktinib is in Phase 1.

Manufacturer: Suzhou Zelgen Biopharmaceuticals Co.,Ltd — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing