Last reviewed 2026-05-22 · How we verify

duastride

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Phase 3 active Small molecule ✓ Verified May 2026 Quality 0/100

duastride is a Small molecule drug developed by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It is currently in Phase 3 development.

Dutastride is a small molecule that inhibits the enzyme steroid 5-alpha-reductase. It is being studied as a treatment for sex disorders in men, often in combination with testosterone enanthate.

Likelihood of approval

58.3% 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).

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	duastride
Sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

The Effect of 5-Alpha Reductase on Testosterone in Men (PHASE3)

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:

duastride CI brief — competitive landscape report
duastride updates RSS · CI watch RSS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) portfolio CI

Frequently asked questions about duastride

What is duastride?

duastride is a Small molecule drug developed by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Who makes duastride?

duastride is developed by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (see full Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) pipeline at /company/eunice-kennedy-shriver-national-institute-of-child-health-and-human-development).

What development phase is duastride in?

duastride is in Phase 3.

Manufacturer: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) — full pipeline
Therapeutic area: All drugs in Other

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