Last reviewed 2026-05-21 · How we verify

SUPLATAST

Phase 2 active Small molecule ✓ Verified May 2026

SUPLATAST is a suplatast drug. It is currently in Phase 2 development.

Suplatast tosilate works by inhibiting the release of chemical mediators from mast cells.

Suplatast tosilate is a small molecule intervention being studied for its efficacy and safety in treating conditions such as Idiopathic Pulmonary Fibrosis and Chronic Cough. It is being investigated in a randomized, double-blind, placebo-controlled trial as part of the COSMIC-IPF study.

Likelihood of approval

16.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	SUPLATAST
Drug class	suplatast
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Imagine your body's immune system is like a fire alarm that goes off when it senses something is wrong. Mast cells are like the alarm sensors that release chemical signals to alert the rest of the body. Suplatast tosilate helps to turn down the volume on these alarm signals, reducing the symptoms of asthma and allergic rhinitis.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF) (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:

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

Frequently asked questions about SUPLATAST

What is SUPLATAST?

SUPLATAST is a suplatast drug.

How does SUPLATAST work?

Suplatast tosilate works by inhibiting the release of chemical mediators from mast cells.

What drug class is SUPLATAST in?

SUPLATAST belongs to the suplatast class. See all suplatast drugs at /class/suplatast.

What development phase is SUPLATAST in?

SUPLATAST is in Phase 2.

Drug class: All suplatast drugs
Therapeutic area: All drugs in Immunology

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