Last reviewed 2026-04-20 · How we verify

Acetamin (ACEDAPSONE)

Phase 2 active Small molecule

Acetamin (generic name: ACEDAPSONE) is a acedapsone drug. It is currently in Phase 2 development.

Acedapsone works by inhibiting the enzyme dihydropteroate synthase, which is involved in the synthesis of folic acid.

Acedapsone, also known as Acetamin, is a small molecule drug in the acedapsone class. Its original development is attributed to an unknown entity, and its current ownership is also unclear. The exact target of acedapsone is unknown, and it has not been approved by the FDA for any indications. As a result, there is limited information available on its commercial status, pharmacokinetics, or safety profile. Further research is needed to fully understand acedapsone's properties and potential applications.

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	ACEDAPSONE
Drug class	acedapsone
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of it like a roadblock in a factory. Acedapsone blocks the production of a key component, folic acid, which is necessary for certain bacteria to grow and multiply. By stopping this process, acedapsone can help prevent the spread of infections.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures (NA)

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:

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

Frequently asked questions about Acetamin

What is Acetamin?

Acetamin (ACEDAPSONE) is a acedapsone drug.

How does Acetamin work?

Acedapsone works by inhibiting the enzyme dihydropteroate synthase, which is involved in the synthesis of folic acid.

What is the generic name of Acetamin?

ACEDAPSONE is the generic (nonproprietary) name of Acetamin.

What drug class is Acetamin in?

Acetamin belongs to the acedapsone class. See all acedapsone drugs at /class/acedapsone.

What development phase is Acetamin in?

Acetamin is in Phase 2.

Drug class: All acedapsone drugs
Therapeutic area: All drugs in Metabolic

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