TRETINOIN
Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.
Details
- Status
- Prescription
- First Approved
- 1998-06-19
- Routes
- ORAL, TOPICAL
- Dosage Forms
- CAPSULE, GEL, CREAM, SOLUTION
Companies
TRETINOIN Approval History
What TRETINOIN Treats
26 FDA approvalsOriginally approved for its first indication in 1998 . Covers 26 distinct patient populations.
- Other (26)
Other
(26 approvals)- • Approved indication (Jun 1998)Letter
- • Approved indication (Dec 1998)Label Letter
- • Approved indication (Jan 1999)Label Letter
- • Approved indication (Feb 2000)Letter
- • Approved indication (Jun 2002)
- • Approved indication (Sep 2005)
- • Approved indication (Jun 2007)Letter
- • Approved indication (Mar 2010)
- • Approved indication (Oct 2012)
- • Approved indication (Oct 2012)
- • Approved indication (Jul 2013)Label Letter
- • Approved indication (Aug 2015)
- • Approved indication (Dec 2016)
- • Approved indication (Jan 2019)
- • Approved indication (Jan 2019)
- • Approved indication (Jan 2023)
- • Approved indication (Apr 2024)
- • Approved indication (Apr 2024)
- • Approved indication (Jan 2025)
- • Approved indication (Feb 2025)
- • Approved indication (Mar 2025)
- • Approved indication (Jul 2025) New
- • Approved indication (Aug 2025) New
- • Approved indication (Feb 2026) New
- • Approved indication (Mar 2026) New
- • Approved indication (May 2026) New
TRETINOIN Boxed Warning
EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME • Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin capsules and for 1 month after the last dose. Advise males w...
WARNING: EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME • Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin capsules and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)] . • Differentiation Syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with APL who received tretinoin capsules. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding tretinoin capsules for moderate and severe Differentiation Syndrome until resolution [see Warnings and Precautions (5.2)] . WARNING: EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. • Embryo-Fetal Toxicity: tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin capsules and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose. (5.1, 8.1, 8.3) • Differentiation Syndrome, which can be
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
TRETINOIN FDA Label Details
Indications & Usage
FDA Label (PDF)Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are a retinoid indicated for induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL), characterized by presence of t(15;17)...
WARNING: EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME • Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before i...
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RETIN-A
Full clinical data, patents, trials, and competitive landscape for tretinoin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.