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Data updated: Jun 17, 2026

RENOVA (tretinoin)

Dermatology Approved 1995-12-29

RENOVA is indicated for the treatment of Facial Wrinkles.

Source: FDA Label • VALEANT PHARMS NORTH
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Discontinued
First Approved
1995-12-29
Routes
TOPICAL
Dosage Forms
CREAM

Companies

VALEANT PHARMS NORTH
Active Ingredient: TRETINOIN

RENOVA Approval History

1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
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2010
2011
2012
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2014
2015
2016
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2019
2020
2021
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2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 1995 to 2016
May 2016 SUPPL
Mfg · Manufacturing (CMC)
Sep 2014 SUPPL
Mfg · Manufacturing (CMC)
Jun 2014 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What RENOVA Treats

1 indications

RENOVA is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Facial Wrinkles
Source: FDA Label
📋

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.

RENOVA FDA Label Details

Indications & Usage

FDA Label (PDF)

RENOVA is indicated for the treatment of Facial Wrinkles.

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Data Sources

FDA Approval: NDA019963 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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