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Late-StageResearch compound

Dutasteride

Dual 5-alpha-reductase inhibitor (type I + II). FDA-approved for BPH (Avodart 0.5 mg), off-label for androgenetic alopecia (approved in South Korea/Japan). Reduces serum DHT by ~90-95%, more strongly than finasteride.

Dutasteride vial

Related comparisons

Finasteride vs Dutasteride

WHAT IS DUTASTERIDE?

Detailed overview

Dutasteride is a synthetic 4-azasteroid developed by GSK (Avodart, FDA approval for BPH in 2001). Unlike finasteride, it inhibits BOTH 5-alpha-reductase isoenzymes (type I + II), thereby reducing serum DHT levels by ~90-95% (vs finasteride ~70%). For androgenetic alopecia it is OFF-LABEL in the USA and the EU, but in South Korea (2009) and Japan (2015) it is officially approved for hair loss at the 0.5 mg dose. According to the phase III dose-ranging study (Gubelin Harcha 2014, PMID 24411083, 917 men), 0.5 mg dutasteride increased hair count and thickness significantly more than finasteride 1 mg or placebo. Due to the exceptionally long ~5-week half-life, the active substance is eliminated slowly and steady state is reached over several months.

ATC code

G04CB02

Prescription status

Prescription (Rx); off-label for AGA

Mechanism of action

Dual 5-alpha-reductase (I + II) inhibition, ~90-95% DHT reduction

Half-life

~5 weeks (terminal) – far longer than finasteride

Onset of action

3-6 months (hair stabilization), 6-12 months (regrowth)

Data console

Lab data

/lab/molecular-data.jsonLIVE
> Classification-
> StructureN/A
> Molecular weightN/A
> Target area-
> Storage2–8°C
> Stability~30 days reconstituted

Safety

Side effects, stop signs, contraindications

Side effects · 6

  • Sexual side effects: decreased libido, erectile dysfunction and ejaculation disorder (~1-4% each); sometimes slightly more frequent than with finasteride due to the fuller androgen blockade, mostly reversible after discontinuation.
  • Breast changes: gynaecomastia, breast tenderness and pain; rarely a breast lump or nipple discharge that must be evaluated.
  • Mood disorders: depression and decreased libido reported; a class warning for 5-alpha-reductase inhibitors, discontinue and seek medical advice if psychiatric symptoms occur.
  • PSA decreases by ~50%: prostate-specific antigen becomes falsely low, so during prostate cancer screening the measured PSA must be doubled to avoid a false negative.
  • Hypersensitivity and skin reactions: rash, pruritus, urticaria, localized edema and (rarely) angioedema; immediate discontinuation if an allergic reaction occurs.
  • Slightly increased incidence of high-grade prostate cancer (Gleason 8-10) in the REDUCE trial, while overall prostate cancer risk fell; with no difference in overall survival.

Contraindications · 4

  • Pregnancy
  • Women of childbearing potential
  • Severe hepatic impairment
  • Hypersensitivity

Related Hair & Skin

Same therapeutic category

Studies

Related research and clinical findings

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Educational hair and skin info from official sources (PubMed, FDA, EMA). Does NOT replace medical consultation. Talk to a dermatologist!

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MolekulaX Editorial Team·Source-verified · PubMed · FDA · EMA
Updated: June 19, 2026

The information here is strictly for educational and scientific purposes. It does not replace medical advice or clinical consultation, and it does not encourage illegal substance or pharmaceutical use. Data is sourced. When in doubt, consult your doctor.