Last reviewed 2026-04-20 · How we verify

ASTODRIMER

Phase 3 active Small molecule Quality 20/100

ASTODRIMER is a drug. It is currently in Phase 3 development for Antimicrobial substance.

ASTODRIMER works by interfering with the growth and replication of microorganisms.

ASTODRIMER is a small molecule drug with antimicrobial properties. Its exact mechanism of action is not well-documented, but it is known to be effective against certain microorganisms. ASTODRIMER is approved for use as an antimicrobial substance, but its target and drug class are unknown. The commercial status of ASTODRIMER is unclear, and it is not known whether it is patented or available as a generic product. Further research is needed to fully understand the safety and efficacy of ASTODRIMER.

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	ASTODRIMER
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 3

Mechanism of action

Imagine your body is like a garden, and microorganisms are like weeds. ASTODRIMER is like a special kind of herbicide that helps to kill or prevent the growth of these weeds, keeping your body healthy and free from infection.

Approved indications

Antimicrobial substance

Common side effects

Vulvovaginal candidiasis
UTI
Headache
Vulvovaginal mycotic infection
Nasopharyngitis

Key clinical trials

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:

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

Frequently asked questions about ASTODRIMER

What is ASTODRIMER?

ASTODRIMER is a Small molecule drug, indicated for Antimicrobial substance.

How does ASTODRIMER work?

ASTODRIMER works by interfering with the growth and replication of microorganisms.

What is ASTODRIMER used for?

ASTODRIMER is indicated for Antimicrobial substance.

What development phase is ASTODRIMER in?

ASTODRIMER is in Phase 3.

What are the side effects of ASTODRIMER?

Common side effects of ASTODRIMER include Vulvovaginal candidiasis, UTI, Headache, Vulvovaginal mycotic infection, Nasopharyngitis.

Therapeutic area: All drugs in Infectious Disease
Indication: Drugs for Antimicrobial substance

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