Tamsulosin

Evidence Level: L5

Predicted Indications: 10

---

Table of Contents

1. Tamsulosin
2. Tamsulosin: From Benign Prostatic Hyperplasia to Ambras Type Hypertrichosis Universalis Congenita
   1. One-Sentence Summary
   2. Quick Overview
   3. Why is This Prediction Reasonable?
   4. Clinical Trial Evidence
   5. Literature Evidence
   6. Singapore Market Information
   7. Safety Considerations
   8. Conclusion and Next Steps
   9. Disclaimer

---

## Pharmacist Assessment Report

Tamsulosin: From Benign Prostatic Hyperplasia to Ambras Type Hypertrichosis Universalis Congenita

One-Sentence Summary

Tamsulosin is an alpha-1 adrenergic blocker originally used to treat benign prostatic hyperplasia (BPH). The TxGNN model predicts it may be effective for Ambras type hypertrichosis universalis congenita, but no clinical trials and no supporting publications currently back this prediction. It is a model prediction only.

Quick Overview

Item	Content
Original Indication	Benign prostatic hyperplasia
Predicted New Indication	Ambras type hypertrichosis universalis congenita
TxGNN Prediction Score	99.996%
Evidence Level	L5
Singapore Market Status	✓ Marketed
Number of Registrations	8
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Based on known information, tamsulosin is an alpha-1A/1D adrenergic receptor antagonist. Its efficacy in BPH is established, where it relaxes smooth muscle in the prostate and bladder neck. No mechanistic link to the new indication has been established.

Ambras syndrome is a rare congenital condition involving excessive hair growth, with a genetic basis. The data compiled for this report show no established connection between alpha-1 adrenergic blockade and that genetic basis. The high TxGNN score (99.996%, rank 168) likely reflects proximity in the knowledge graph rather than a demonstrated biological mechanism.

Other top predictions are also in hair and congenital disorders, including hypertrichosis, hair shaft abnormalities, hypotrichosis, and alopecia. None has clinical trial or supportive literature evidence. This prediction should be treated as a hypothesis only.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available for the predicted indication.

Singapore Market Information

Eight valid single-ingredient registrations are listed. The approved indication text is not recorded in the data compiled for this report. Five are shown below.

Authorization Number	Product Name	Dosage Form	Approved Indication
SIN15476P	TAMSIN Prolonged Release Tablet 0.4mg	Film-coated extended-release tablet	Not recorded
SIN15573P	TASULOSE Prolonged-Release Film-Coated Tablets 400 mcg	Film-coated extended-release tablet	Not recorded
SIN16191P	TAMSULOSIN-TEVA Prolonged Release Film-Coated Tablet 400mcg	Film-coated extended-release tablet	Not recorded
SIN13696P	Harnal OCAS Prolonged Release Film-coated Tablet 400mcg	Film-coated extended-release tablet	Not recorded
SIN16678P	LOTUFLO-D Capsules 0.5 mg/0.4 mg	Capsule	Not recorded

Safety Considerations

• Disease-related cautions (from knowledge graph, not label text): Contraindication links exist for multiple system atrophy, postural orthostatic tachycardia syndrome, orthostatic hypotension, liver disease, gallbladder disease, priapism, and intraoperative floppy iris syndrome.
• Drug Interactions: 100 interactions were found. Main ones:
  • Major: Clarithromycin
  • Moderate: Bupropion, Aprepitant, Morphine, Lorcaserin, Cimetidine, Clotrimazole, Miconazole, and SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin)

For label-based warnings and contraindications, please refer to the package insert.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has a very high model score, but there are no clinical trials or publications and no plausible mechanism. The evidence level is L5 (model prediction only). Label-based safety data are also missing.

To proceed, the following is needed:

• Mechanism of action data and a plausible biological link between alpha-1 blockade and the genetic basis of Ambras syndrome
• Preclinical or mechanistic studies supporting the prediction
• Package insert warnings and contraindications from HSA for safety screening
• A review of whether other predicted indications, such as hypertrichosis and alopecia, have stronger supporting evidence

  Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.

---