Wednesday, July 8, 2026

Drug profile · INN

terbinafine

terbinafine (APO-TERBINAFINE) is a squalene monooxygenase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — terbinafine
US status
approved
Class
Route
TOPICAL
Patents
0
Programs
4
Data quality
0.84

Quick answer

terbinafine (APO-TERBINAFINE) is a squalene monooxygenase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN terbinafine
Brand APO-TERBINAFINE
Mechanism Squalene monooxygenase inhibitor
Target Squalene monooxygenase
Route TOPICAL
Formulation GEL

Mechanism of action

Squalene monooxygenase inhibitor

Primary target: Squalene monooxygenase

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. FMGX-CS-302 Phase 3 · Anaxis Pharma · Invasive mold infections caused by Aspergillus spp., Fusariu
  2. TERBINAFINE HYDROCHLORIDE (1%) Phase 2 · United Therapeutics Europe · Tinea Pedis
  3. Terbinafin "Moberg Pharma" for Distal Subungual Onychomycosis Phase 2 · Anaxis Pharma · Distal Subungual Onychomycosis
  4. Terbinafine HCl 250mg tablets Phase 1 · Teva Pharma · Healthy

Related & competitor drugs

  1. naftifine hydrochloride Squalene monooxygenase inhibitor
  2. butenafine hydrochloride Squalene monooxygenase inhibitor
  3. terbinafine hydrochloride Squalene monooxygenase inhibitor

Frequently asked questions

What is terbinafine?

terbinafine (APO-TERBINAFINE) is a squalene monooxygenase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for terbinafine?

APO-TERBINAFINE is a marketed brand name for terbinafine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of terbinafine?

terbinafine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.