Last reviewed 2026-05-14 · How we verify

Differin 0.3% Topical Gel

Aleor Dermaceuticals Limited · Phase 3 active Small molecule

Differin 0.3% Topical Gel is a Retinoid (third-generation) Small molecule drug developed by Aleor Dermaceuticals Limited. It is currently in Phase 3 development for Acne vulgaris (moderate severity).

Adapalene is a third-generation retinoid that binds to retinoic acid receptors to normalize skin cell differentiation and reduce inflammation in acne.

Adapalene is a third-generation retinoid that binds to retinoic acid receptors to normalize skin cell differentiation and reduce inflammation in acne. Used for Acne vulgaris (moderate severity).

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Differin 0.3% Topical Gel
Sponsor	Aleor Dermaceuticals Limited
Drug class	Retinoid (third-generation)
Target	Retinoic acid receptor gamma (RARγ)
Modality	Small molecule
Therapeutic area	Dermatology
Phase	Phase 3

Mechanism of action

Adapalene selectively activates retinoic acid receptor gamma (RARγ) and other retinoid receptors, promoting keratinocyte differentiation and reducing comedone formation. It decreases sebum production and has anti-inflammatory properties that help resolve acne lesions. The 0.3% gel formulation represents a higher-strength topical delivery for enhanced efficacy in moderate acne.

Approved indications

Acne vulgaris (moderate severity)

Common side effects

Erythema (redness)
Dryness and peeling
Irritation
Photosensitivity

Key clinical trials

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:

Differin 0.3% Topical Gel CI brief — competitive landscape report
Differin 0.3% Topical Gel updates RSS · CI watch RSS
Aleor Dermaceuticals Limited portfolio CI

Frequently asked questions about Differin 0.3% Topical Gel

What is Differin 0.3% Topical Gel?

Differin 0.3% Topical Gel is a Retinoid (third-generation) drug developed by Aleor Dermaceuticals Limited, indicated for Acne vulgaris (moderate severity).

How does Differin 0.3% Topical Gel work?

Adapalene is a third-generation retinoid that binds to retinoic acid receptors to normalize skin cell differentiation and reduce inflammation in acne.

What is Differin 0.3% Topical Gel used for?

Differin 0.3% Topical Gel is indicated for Acne vulgaris (moderate severity).

Who makes Differin 0.3% Topical Gel?

Differin 0.3% Topical Gel is developed by Aleor Dermaceuticals Limited (see full Aleor Dermaceuticals Limited pipeline at /company/aleor-dermaceuticals-limited).

What drug class is Differin 0.3% Topical Gel in?

Differin 0.3% Topical Gel belongs to the Retinoid (third-generation) class. See all Retinoid (third-generation) drugs at /class/retinoid-third-generation.

What development phase is Differin 0.3% Topical Gel in?

Differin 0.3% Topical Gel is in Phase 3.

What are the side effects of Differin 0.3% Topical Gel?

Common side effects of Differin 0.3% Topical Gel include Erythema (redness), Dryness and peeling, Irritation, Photosensitivity.

What does Differin 0.3% Topical Gel target?

Differin 0.3% Topical Gel targets Retinoic acid receptor gamma (RARγ) and is a Retinoid (third-generation).

Drug class: All Retinoid (third-generation) drugs
Target: All drugs targeting Retinoic acid receptor gamma (RARγ)
Manufacturer: Aleor Dermaceuticals Limited — full pipeline
Therapeutic area: All drugs in Dermatology
Indication: Drugs for Acne vulgaris (moderate severity)

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