Dutasteride
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Dutasteride
- Dutasteride: From Benign Prostatic Hyperplasia to Ambras Type Hypertrichosis Universalis Congenita
Dutasteride: From Benign Prostatic Hyperplasia to Ambras Type Hypertrichosis Universalis Congenita
One-Sentence Summary
Dutasteride is a 5-alpha-reductase inhibitor originally used to treat benign prostatic hyperplasia (BPH). The TxGNN model predicts it may be effective for Ambras type hypertrichosis universalis congenita, but there are currently 0 clinical trials and 0 publications directly supporting this prediction, so it rests on model output alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Benign prostatic hyperplasia (the approved indication text is not available in the Singapore registration records; this is taken from the knowledge-graph indication) |
| Predicted New Indication | Ambras type hypertrichosis universalis congenita |
| TxGNN Prediction Score | 99.998% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 10 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. From known pharmacology, dutasteride inhibits type 1 and type 2 5-alpha-reductase and lowers dihydrotestosterone (DHT). This is how it shrinks the prostate in BPH.
The link to the predicted indication is weak. Ambras syndrome is a congenital hypertrichosis caused by genomic rearrangements that alter TRPS1 regulation, so it is not primarily DHT-driven. The very high TxGNN score is a model output reflecting network proximity in the knowledge graph. It is not clinical evidence.
Other top-ranked predictions are also mostly speculative. These include generalised hypertrichosis, hair shaft abnormalities, hypotrichosis simplex of the scalp, and several developmental malformation syndromes. Hair-related predictions are somewhat more plausible because dutasteride is used off-label for androgenetic alopecia. However, the genetic hair disorders listed are generally not androgen-mediated. The malformation syndromes (dental/periodontal, Dandy-Walker) have no credible mechanistic link.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
For the top prediction, no related literature is available.
Across the other ten predictions, one paper was retrieved. It relates to diffuse alopecia areata (rank 8) and offers only indirect support:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 41714473 | 2026 | Review | American Journal of Clinical Dermatology | Narrative review of pathophysiology, evaluation and treatment of androgenetic alopecia in women. It concerns a different hair-loss disorder, not alopecia areata. |
Singapore Market Information
All 10 licences are valid single-ingredient registrations. The approved indication text is not recorded in the registration data. Product names containing "0.5/0.4" or "0.5mg/0.4mg" are dutasteride combined with tamsulosin pellets in the same capsule.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN12434P | Avodart Soft Capsule 0.5 mg | Capsule, liquid filled | Not recorded |
| SIN14181P | Duodart Capsules 0.5mg/0.4mg | Capsule | Not recorded |
| SIN16448P | Dutabit 0.5 Soft Capsules 0.5mg | Capsule, liquid filled | Not recorded |
| SIN16633P | Dutabit Plus 0.5/0.4 Capsules 0.5mg/0.4mg | Capsule | Not recorded |
| SIN15882P | Rafuster Soft Capsules 0.5 mg | Capsule, liquid filled | Not recorded |
Five further registrations are not listed here: Intasteride, Aripsa, Dutasvitae, Lotuflo-D, and Duoflow.
Safety Considerations
- Contraindications (from the knowledge graph, not label text): multiple system atrophy, postural orthostatic tachycardia syndrome, orthostatic hypotension, liver disease, gallbladder disease, priapism, intraoperative floppy iris syndrome. Several of these probably relate to the tamsulosin component of the combination products rather than dutasteride alone, so they should be verified against the package insert.
- Drug Interactions: 100 interactions were found. The moderate-level ones are aprepitant, cimetidine, clarithromycin, clotrimazole and miconazole. These are plausibly CYP3A4-related. Other interactions in the list, such as pantoprazole, metformin, simvastatin and prednisone, have an unknown severity level.
- Developmental concern: 5-alpha-reductase inhibitors can affect the external genitalia of a male fetus. This matters particularly for the predicted congenital and developmental conditions, and for any use in women of childbearing potential or children.
The package insert warnings and contraindications were not available and should be reviewed.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no supporting trials or literature (evidence level L5). The mechanism is speculative because Ambras syndrome is not DHT-driven. The drug carries fetal developmental concerns. Singapore registration shows the drug is available, but that does not support the new indication.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA website
- Mechanism of action data from DrugBank
- Preclinical or case-level evidence connecting 5-alpha-reductase inhibition to TRPS1-related hair growth
- Consideration of whether a better-supported hair-related prediction (such as hypotrichosis simplex of the scalp) should be prioritised instead
- A safety plan for the pregnancy and pediatric exposure risk if any developmental or congenital condition is pursued
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.