Last reviewed 2026-06-02 · How we verify

Tazaroc Gel

Stiefel, a GSK Company · Phase 1 active Small molecule ✓ Verified Jun 2026

Tazaroc Gel is a Small molecule drug developed by Stiefel, a GSK Company. It is currently in Phase 1 development. Also known as: Tazorac.

Tazaroc Gel is a topical treatment used to study the bioavailability of tazarotene in subjects with acne vulgaris. It is a formulation of tazarotene, a compound that has been studied for its potential therapeutic effects.

Likelihood of approval

12.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
Stiefel, a GSK Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Tazaroc Gel
Also known as	Tazorac
Sponsor	Stiefel, a GSK Company
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Tazaroc Gel CI brief — competitive landscape report
Tazaroc Gel updates RSS · CI watch RSS
Stiefel, a GSK Company portfolio CI

Frequently asked questions about Tazaroc Gel

What is Tazaroc Gel?

Tazaroc Gel is a Small molecule drug developed by Stiefel, a GSK Company.

Who makes Tazaroc Gel?

Tazaroc Gel is developed by Stiefel, a GSK Company (see full Stiefel, a GSK Company pipeline at /company/stiefel-a-gsk-company).

Is Tazaroc Gel also known as anything else?

Tazaroc Gel is also known as Tazorac.

What development phase is Tazaroc Gel in?

Tazaroc Gel is in Phase 1.

Manufacturer: Stiefel, a GSK Company — full pipeline
Also known as: Tazorac

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing