TRETINOIN MICROSPHERE (tretinoin)
Tretinoin (oral capsules) is a retinoid indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL). It is specifically indicated for patients characterized by the presence of the t(15;17) translocation or PML/RARα gene expression who are refractory to, have relapsed from, or have contraindications to anthracycline-based chemotherapy. IMPROVED_HOW_IT_WORKS: Tretinoin induces cytodifferentiation and inhibits the proliferation of APL cells. In patients with APL, the medication triggers the maturation of primitive promyelocytes derived from the leukemic clone, leading to a subsequent repopulation of the bone marrow and peripheral blood with normal, polyclonal hematopoietic cells. While the exact molecular mechanism of action is not fully elucidated, it effectively transforms malignant cells into mature, functional cells.
How TRETINOIN MICROSPHERE Works
The medication works by triggering the maturation of immature leukemic cells and reducing their ability to multiply. This process allows the bone marrow and peripheral blood to be repopulated with normal, healthy blood cells. While the exact biological process is not fully understood, it effectively transforms primitive promyelocytes into more developed cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-08-22
- Routes
- TOPICAL
- Dosage Forms
- GEL
TRETINOIN MICROSPHERE Approval History
What TRETINOIN MICROSPHERE Treats
1 indicationsTRETINOIN MICROSPHERE is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Promyelocytic Leukemia
TRETINOIN MICROSPHERE 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
TRETINOIN MICROSPHERE Competitive Set
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Indication competitors
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What's emerging in TRETINOIN MICROSPHERE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRETINOIN MICROSPHERE treats. First-in-class if their pivotal trials read out positive.
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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 MICROSPHERE FDA Label Details
Indications & Usage
TRETINOIN MICROSPHERE is indicated for the treatment of Acute Promyelocytic Leukemia.
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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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment