Last reviewed 2026-04-20 · How we verify

Fortimicin A (ASTROMICIN)

Phase 2 active Small molecule

Fortimicin A (generic name: ASTROMICIN) is a drug. It is currently in Phase 2 development.

Fortimicin A works by inhibiting bacterial protein synthesis.

Fortimicin A, also known as Astromicin, is a small molecule antibiotic originally developed by Merck & Co. Its commercial status is currently unknown, and it is not FDA-approved for any indications. The target and drug class of Fortimicin A are also unknown. It has a half-life of 2.0 hours, but its bioavailability and off-patent status are not documented. Further research is needed to understand its mechanism of action and potential clinical applications.

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	ASTROMICIN
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like factories that make proteins to keep you healthy. Bacteria are like tiny factories that make proteins to harm you. Fortimicin A stops these bacterial factories from working by binding to a crucial part of the protein-making machinery.

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:

Fortimicin A CI brief — competitive landscape report
Fortimicin A updates RSS · CI watch RSS

Frequently asked questions about Fortimicin A

What is Fortimicin A?

Fortimicin A (ASTROMICIN) is a Small molecule drug.

How does Fortimicin A work?

Fortimicin A works by inhibiting bacterial protein synthesis.

What is the generic name of Fortimicin A?

ASTROMICIN is the generic (nonproprietary) name of Fortimicin A.

What development phase is Fortimicin A in?

Fortimicin A is in Phase 2.

Therapeutic area: All drugs in Infectious Disease

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