Last reviewed 2026-04-19 · How we verify

ZL-3101

Zai Lab Pty. Ltd. · Phase 2 active Small molecule

ZL-3101 is a Small molecule drug developed by Zai Lab Pty. Ltd.. It is currently in Phase 2 development. Also known as: Fugan ointment.

ZL-3101 is a novel therapeutic candidate developed by Zai Lab Pty. Ltd. for the treatment of subacute eczema. It has completed Phase 2 trials, demonstrating promising efficacy and safety profiles. The drug's mechanism of action targets inflammatory pathways, positioning it as a potential best-in-class therapy in its class.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	ZL-3101
Also known as	Fugan ointment
Sponsor	Zai Lab Pty. Ltd.
Modality	Small molecule
Phase	Phase 2

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:

ZL-3101 CI brief — competitive landscape report
ZL-3101 updates RSS · CI watch RSS
Zai Lab Pty. Ltd. portfolio CI

Frequently asked questions about ZL-3101

What is ZL-3101?

ZL-3101 is a Small molecule drug developed by Zai Lab Pty. Ltd..

Who makes ZL-3101?

ZL-3101 is developed by Zai Lab Pty. Ltd. (see full Zai Lab Pty. Ltd. pipeline at /company/zai-lab-pty-ltd).

Is ZL-3101 also known as anything else?

ZL-3101 is also known as Fugan ointment.

What development phase is ZL-3101 in?

ZL-3101 is in Phase 2.

Manufacturer: Zai Lab Pty. Ltd. — full pipeline
Also known as: Fugan ointment

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