Last reviewed 2026-05-26 · How we verify

Sulfalepsin (SUCLOFENIDE)

Phase 2 active Small molecule ✓ Verified May 2026

Sulfalepsin (generic name: SUCLOFENIDE) is a suclofenide drug. It is currently in Phase 2 development.

Suclofenide works by inhibiting a specific ion channel to modulate the activity of certain cells.

Sulfalepsin, also known as Suclofenide, is a small molecule drug in the suclofenide class. Its exact target is unknown, but it is used to treat certain conditions. The commercial status of Suclofenide is unclear, and it may be patented or have generic manufacturers. Key safety considerations are not well-documented. Further research is needed to fully understand its pharmacology and clinical use.

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	SUCLOFENIDE
Drug class	suclofenide
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks on a door. Suclofenide is a key that fits into these locks, but instead of opening the door, it blocks the lock from working properly. This helps to reduce the activity of certain cells that may be contributing to a disease or condition.

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:

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

Frequently asked questions about Sulfalepsin

What is Sulfalepsin?

Sulfalepsin (SUCLOFENIDE) is a suclofenide drug.

How does Sulfalepsin work?

Suclofenide works by inhibiting a specific ion channel to modulate the activity of certain cells.

What is the generic name of Sulfalepsin?

SUCLOFENIDE is the generic (nonproprietary) name of Sulfalepsin.

What drug class is Sulfalepsin in?

Sulfalepsin belongs to the suclofenide class. See all suclofenide drugs at /class/suclofenide.

What development phase is Sulfalepsin in?

Sulfalepsin is in Phase 2.

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

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