Last reviewed 2026-05-23 · How we verify

SULISATIN

Phase 2 active Small molecule ✓ Verified May 2026

SULISATIN is a sulisatin drug. It is currently in Phase 2 development.

Sulisatin works by interacting with a specific target in the body, but the exact nature of this interaction is not yet understood.

Sulisatin is a small molecule. It has synonyms including Sulisatin, Sulisatina, and Sulisatine.

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	SULISATIN
Drug class	sulisatin
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine sulisatin as a key that fits into a lock in the body. When it binds to this lock, it can either turn it on or off, or change the way it works. This can help to treat certain conditions, but more research is needed to understand exactly how it works and what effects it has on the body.

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:

SULISATIN CI brief — competitive landscape report
SULISATIN updates RSS · CI watch RSS

Frequently asked questions about SULISATIN

What is SULISATIN?

SULISATIN is a sulisatin drug.

How does SULISATIN work?

Sulisatin works by interacting with a specific target in the body, but the exact nature of this interaction is not yet understood.

What drug class is SULISATIN in?

SULISATIN belongs to the sulisatin class. See all sulisatin drugs at /class/sulisatin.

What development phase is SULISATIN in?

SULISATIN is in Phase 2.

Drug class: All sulisatin drugs
Therapeutic area: All drugs in Other

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