Last reviewed 2026-05-22 · How we verify

SULFAMETROLE

Phase 2 active Small molecule ✓ Verified May 2026

SULFAMETROLE is a sulfametrole drug. It is currently in Phase 2 development.

Sulfamethrole works by inhibiting the enzyme dihydropteroate synthase, which is necessary for bacterial cell wall synthesis.

Sulfamethrole is a small molecule. It is also known by the synonyms Sulfamethrol and Sulfamethrole.

Likelihood of approval

17.3% 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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

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	SULFAMETROLE
Drug class	sulfametrole
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Think of it like a key that fits into a lock. Bacteria need a certain enzyme to build their cell walls, and sulfamethrole blocks that enzyme, preventing the bacteria from building their walls and ultimately killing them.

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:

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

Frequently asked questions about SULFAMETROLE

What is SULFAMETROLE?

SULFAMETROLE is a sulfametrole drug.

How does SULFAMETROLE work?

Sulfamethrole works by inhibiting the enzyme dihydropteroate synthase, which is necessary for bacterial cell wall synthesis.

What drug class is SULFAMETROLE in?

SULFAMETROLE belongs to the sulfametrole class. See all sulfametrole drugs at /class/sulfametrole.

What development phase is SULFAMETROLE in?

SULFAMETROLE is in Phase 2.

Drug class: All sulfametrole drugs
Therapeutic area: All drugs in Infectious Disease

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