Dutasteride
An oral 5-alpha-reductase inhibitor approved for enlarged prostate, widely used off-label for hair loss and approved for that use in some other countries.
Dutasteride Biological Classification
Investigated within physiological and chemical models.
What kind of compound
Small molecule
Small-molecule inhibitor of both type I and type II 5-alpha-reductase, supplied as oral capsules.
Human testing on file
0human records
0 animal · 1 total indexed. Approved drug product in the United States.
Regulatory position
FDA-approved for benign prostatic hyperplasia; off-label for hair loss in the US, approved for male AGA in some other countries.
Studied for
Dual 5-alpha-reductase inhibition
Reviewed 13 November 2026
Known safety concerns in this file
- The approved label carries warnings and precautions, including sexual adverse experiences and prostate-cancer considerations.
- The long half-life means adverse effects may persist after discontinuation.
- Off-label status means the hair-loss risk-benefit discussion is not covered by an approved label.
Commonly compared with
- Finasteride — FDA-approved for male hair loss; type II selective.
- Minoxidil — Approved topical treatment, different mechanism.
What is Dutasteride?
An oral 5-alpha-reductase inhibitor approved for enlarged prostate, widely used off-label for hair loss and approved for that use in some other countries. A dual type I/type II 5-alpha-reductase inhibitor. Its United States approval is for benign prostatic hyperplasia, not hair loss, and it is frequently described as a hair-loss treatment without that distinction being made.
Why are people interested in it?
It inhibits both types of 5-alpha-reductase, so it suppresses DHT more completely than finasteride — a pharmacological difference with an uncertain clinical advantage.
Primary Research Categories
- Hair-growth drugs
- Small-molecule drugs
- Approved drug substances
How does it work in the body?
Inhibits type I and type II 5-alpha-reductase, reducing DHT. The longer half-life means effects and adverse events persist longer after stopping than with finasteride.
Biological Pathway Overview
Dutasteride Receptor & Target Interactions
This compound is evaluated in scientific research for its interactions with target cellular receptors and signaling cascades. Consult the evidence section below for specific peer-reviewed papers.
5-alpha-reductase type I
Named in the published mechanism discussion for this compound.
5-alpha-reductase type II
Named in the published mechanism discussion for this compound.
DHT synthesis
Named in the published mechanism discussion for this compound.
Key Distinction: Approval applies to the specific indication and product on the label, not to every use of the molecule.
What has actually been demonstrated in humans?
Trials and reviews support off-label use in male androgenetic alopecia; Japan and South Korea have approved it for that indication. It is not FDA-approved for hair loss.
Pharmaceutical Reality vs. Unregulated Research Chemicals
FDA-approved for benign prostatic hyperplasia; off-label for hair loss in the US, approved for male AGA in some other countries. Long-term hair outcomes in a United States regulatory context.
What is still uncertain or unknown?
Long-term hair outcomes in a United States regulatory context. The clinical significance of the greater DHT suppression. Persistent adverse effects after discontinuation.
Research at a Glance
Open the full evidence file (1 records)1 record in this file
- REVIEW1
Publication span: 2022
What Has Actually Been Studied
- Comparison of oral minoxidil, finasteride and dutasteride for treating androgenetic alopecia (Journal of Dermatological Treatment, 2022) — Narrative review.
What is Still Unknown
What we know
Editorial reading of the records below, labelled as Therapept analysis. How records are built
What remains uncertain
Preparation and Handling
Lyophilized peptides ship as freeze-dried powders; whatever happens next involves diluents, concentrations and storage conditions that are compound- and product-specific.
United States Regulatory Status
FDA-approved drug substance
Approved Indication: Approved in the United States for benign prostatic hyperplasia, not for androgenetic alopecia. Oral dutasteride for hair loss is off-label in the United States; regulators in Japan and South Korea have approved it for male androgenetic alopecia.
- FDA-approved in the United States for benign prostatic hyperplasia. Therapept found no FDA-approved dutasteride product for androgenetic alopecia.
- A 2022 review records that Japan and South Korea have approved oral dutasteride 0.5 mg daily for male androgenetic alopecia, while United States use for hair loss remains off-label.
- Dutasteride has a long half-life relative to finasteride; the label's warnings and precautions apply. Regulatory status is not a safety assessment.
Technical Chemical SpecificationsClick to view CAS, sequence, and molecular formulas
- Molecular weight
- 528.53 g/mol
- Sequence length
- Not recorded
- CAS number
- 164656-23-9
- PubChem CID
- 6918296
- Compound class
- Small-molecule inhibitor of both type I and type II 5-alpha-reductase, supplied as oral capsules
- Sequence
- Unknown / Unassigned
- Molecular formula
- C27H30F6N2O2
- Molecular weight
- 528.53 g/mol
- CAS number
- 164656-23-9
- PubChem CID
- 6918296
Sources
Last reviewed 13 November 2026 · Compiled by Therapept Editorial · How these records are built