TheraRadar
Data updated: May 26, 2026

RETIN-A (tretinoin)

Dermatology Approved 1971-10-20

RETIN-A is indicated for the treatment of Acne Vulgaris.

Source: FDA Label • VALEANT BERMUDA
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
6
Indications
--
Phase 3 Trials
1
Priority Reviews
54
Years on Market

Details

Status
Prescription
First Approved
1971-10-20
Routes
TOPICAL
Dosage Forms
CREAM, GEL, SWAB, SOLUTION

Companies

VALEANT BERMUDA VALEANT PHARMS NORTH VALEANT INTL BAUSCH
Active Ingredient: TRETINOIN

RETIN-A Approval History

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Original
New Indication
New Form
Label Update
150 FDA actions from 1971 to 2016
May 2016 SUPPL
Mfg · Manufacturing (CMC)
Dec 2015 SUPPL
Mfg · Manufacturing (CMC)
May 2013 SUPPL
Mfg · Manufacturing (CMC)

What RETIN-A Treats

1 indications

RETIN-A is approved for 1 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acne Vulgaris
Source: FDA Label

RETIN-A Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

1

Same target(s) AND same indication — head-to-head.

TWYNEO
MAYNE PHARMA
2021 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CABTREO
BAUSCH
2023 1 indic.
WINLEVI
Sun Pharma
2020 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to RETIN-A

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ACANYA
BENZOYL PEROXIDE
1 shared
BAUSCH
Shared indications:
Acne Vulgaris
ACZONE
DAPSONE
1 shared
ALMIRALL
Shared indications:
Acne Vulgaris
ADAPALENE AND BENZOYL PEROXIDE
ADAPALENE
1 shared
PADAGIS ISRAEL
Shared indications:
Acne Vulgaris
View all 20 similar drugs Pro
📋

Clinical Trial Registry

16 trials
Trial Sponsor ID Phase Status Title
NCT01409161 2010-0981 NCI-2011-02767, 2010-0981 Ph 2 recruiting Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
NCT02339740 results posted AAML1331 NCI-2014-02266, PAAML1331_A01PAMDREVW0 Ph 3 active not recruiting Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia
NCT04919369 OSU-20171 NCI-2021-03310 Ph 1 active not recruiting All-Trans Retinoic Acid (ATRA) and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
NCT02688140 TUD-APOLLO-064 TUD-APOLLO-064 Ph 3 completed Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia
NCT03878524 STUDY00015588 NCI-2020-02743, STUDY00015588 Ph 1 terminated Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
NCT02842827 results posted IMG-7289-CTP-101 IMG-7289-CTP-101, MK-3543-001 Ph 1, Ph 2 completed A Study of Bomedemstat (IMG-7289/MK-3543) With and Without ATRA, in Participants With Advanced Myeloid Malignancies (IMG-7289-CTP-101/MK-3543-001)
NCT03999684 results posted 19-224 Ph 2 completed A Trial of All-trans Retinoic Acid (ATRA) in Advanced Adenoid Cystic Carcinoma
NCT04080869 RP-AV Ph 2 completed Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris
NCT00866918 results posted AAML0631 NCI-2011-01904, CDR0000637184 Ph 3 completed Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
NCT02273102 TCP-ATRA 20140328 Ph 1 completed Study of TCP-ATRA for Adult Patients With AML and MDS
NCT02249767 results posted Tret.2014.10.01.14 Ph 3 completed Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel
NCT01243450 results posted RAM-04 Ph 3 completed Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo
NCT01820624 CASE3912 NCI-2013-00600 Ph 1 completed Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT01406080 FOTEN BR.10.002 Ph 3 completed A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging
NCT01283464 results posted SKM10-R-01 Ph 2 completed Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles
NCT00835198 results posted MA-ACZ0801 Ph 4 completed Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

RETIN-A FDA Label Details

Indications & Usage

FDA Label (PDF)

RETIN-A is indicated for the treatment of Acne Vulgaris.

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Data Sources

FDA Approval: NDA017522 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.