Overview
Tretinoin, also known as all-trans-retinoic acid (ATRA), is a naturally occurring derivative of vitamin A (retinol). It is an oxidation product in the physiological pathway of vitamin A metabolism. In human circulation, tretinoin is normally found at very low concentrations, approximately 4 to 14 nmol/L. Tretinoin exhibits anti-inflammatory, antineoplastic, antioxidant, and free radical-scavenging activities. It has been used in dermatology for many years to treat various skin conditions ranging from acne to wrinkles and activates nuclear receptors to regulate epithelial cell growth and differentiation. Tretinoin is given orally to treat acute promyelocytic leukemia and topically to treat skin conditions such as acne.
Indication
Oral tretinoin is indicated for induction of remission in adults and pediatric patients one year of age and older with acute promyelocytic leukemia (APL), characterized by the presence of t(15;17) translocation or presence of PML/RARα gene expression and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Topical tretinoin is also indicated alone or in combination with benzoyl peroxide or clindamycin for the treatment of acne vulgaris. It is also used in prescription and over-the-counter for treating various skin conditions such as melasma, hyperpigmentation, and photoaging alone or in combination with other drugs.
Associated Conditions
- Acne Vulgaris
- Alopecia
- Cornification and dystrophic skin disorders
- FAB classification M3 Acute promyelocytic leukemia
- Fine Wrinkles
- Photodamaged Skin
- Skin hyperpigmentation
- Keratinization disorders of the feet
- Keratinization disorders of the hand
- Moderate Melasma
- Mottled hyperpigmentation
- Severe Melasma
- Severe, recalcitrant Cystic acne
- Tactile roughness of facial skin
Research Report
Tretinoin (All-trans-Retinoic Acid): A Comprehensive Clinical and Pharmacological Monograph
Section 1: Tretinoin: A Molecular and Historical Profile
Tretinoin, also known as all-trans-retinoic acid (ATRA), is a pivotal small molecule in both dermatology and oncology. As a naturally occurring metabolite of vitamin A (retinol), it plays a fundamental role in the physiological regulation of cell reproduction, proliferation, and differentiation.[1] Its therapeutic application leverages these endogenous functions, modulating gene expression to treat a diverse range of conditions from acne vulgaris and photodamaged skin to the life-threatening malignancy, acute promyelocytic leukemia (APL).[2] This section provides a foundational overview of Tretinoin, detailing its chemical identity, the intricacies of its synthesis, and the significant, albeit complex, history of its discovery and clinical development.
1.1 Chemical Identity and Physicochemical Properties
Tretinoin is a retinoid compound, structurally characterized by a bulky hydrophobic group (a trimethylated cyclohexene ring), a conjugated tetraene side chain, and a polar carboxylic acid functional group.[3] Its precise chemical name is (2E,4E,6E,8E)-3,7-Dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid.[2] The "all-trans" designation is critical, as it refers to the stereochemistry of the four exocyclic double bonds, a configuration essential for its biological activity.[4]
Physically, Tretinoin is a yellow to light-orange crystalline powder that possesses a distinct floral odor.[4] It has a molecular formula of
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/23 | Not Applicable | Not yet recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2025/01/22 | Phase 2 | Recruiting | Hasanuddin University | ||
2024/12/12 | Phase 2 | Recruiting | |||
2024/11/26 | Phase 3 | Recruiting | |||
2024/10/17 | Phase 2 | Not yet recruiting | |||
2024/07/30 | Phase 2 | Recruiting | Gabriel Tinoco | ||
2024/07/03 | Phase 2 | Recruiting | Rita Assi | ||
2024/06/03 | Phase 1 | Recruiting | |||
2024/04/17 | Not Applicable | Recruiting | First Affiliated Hospital of Zhejiang University | ||
2023/12/26 | Not Applicable | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sincerus Florida, LLC | 72934-1017 | TOPICAL | 0.05 g in 100 g | 4/23/2019 | |
| DR. THROWER'S SKINCARE, INC. | 69299-301 | TOPICAL | 0.1 g in 100 g | 5/22/2015 | |
| Sincerus Florida, LLC | 72934-1200 | TOPICAL | 0.025 g in 100 g | 7/2/2020 | |
| Par Pharmaceutical, Inc. | 10370-268 | ORAL | 10 mg in 1 1 | 4/13/2023 | |
| Dispensing Solutions, Inc. | 55045-3691 | TOPICAL | 1 mg in 1 g | 7/18/2013 | |
| Encube Ethicals Private Limited | 21922-050 | TOPICAL | 0.25 mg in 1 g | 12/28/2023 | |
| Oceanside Pharmaceuticals | 68682-515 | TOPICAL | 0.8 mg in 1 g | 10/30/2023 | |
| Bryant Ranch Prepack | 72162-2158 | TOPICAL | 0.5 mg in 1 g | 12/8/2023 | |
| Sincerus Florida, LLC | 72934-1088 | TOPICAL | 0.025 g in 100 g | 5/17/2019 | |
| Rebel Distributors Corp | 21695-804 | TOPICAL | 0.5 mg in 1 g | 1/1/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| RETACNYL 0.05 CREAM 0.05% | SIN08098P | CREAM | 0.05% | 3/28/1995 | |
| VESANOID CAPSULE 10 mg | SIN08057P | CAPSULE | 10 mg | 3/9/1995 | |
| RETRIEVE CREAM 0.05% w/w | SIN12368P | CREAM | 0.5 mg/g | 7/24/2003 | |
| STIEVA-A CREAM 0.05% | SIN03890P | CREAM | 0.05% w/w | 2/23/1990 | |
| RETACNYL 0.025 CREAM 0.025% | SIN08095P | CREAM | 0.025% | 3/28/1995 | |
| TRETINON CREAM 0.05% W/W | SIN16390P | CREAM | 0.05 % w/w | 11/30/2021 | |
| STIEVA-A CREAM 0.025% | SIN03877P | CREAM | 0.025% w/w | 2/10/1990 | |
| TRI-LUMA CREAM | SIN12607P | CREAM | 0.5 mg/g | 10/19/2004 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ACTA CREAM 0.1% | N/A | N/A | N/A | 12/29/1989 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RETRIEVE tretinoin 0.5mg/g cream tube | 15553 | Medicine | A | 9/20/1991 | |
| ACNATAC clindamycin (as phosphate) 1.0% w/w and tretinoin 0.025% w/w topical gel, tube | 232394 | Medicine | A | 3/29/2016 | |
| VESANOID tretinoin 10mg capsules bottle | 53160 | Pharmaco Australia Ltd | Medicine | A | 11/1/1995 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| RETISOL-A | 02008726 | Cream - Topical | 0.1 % | 12/31/1993 | |
| VITINOIN - CRM 0.1% | penederm inc. | 02125315 | Cream - Topical | .1 % | 12/31/1995 |
| RETISOL-A | 02008688 | Cream - Topical | 0.01 % | 12/31/1993 | |
| VITAMIN A ACID 0.025% CREAM | sanofi-aventis canada inc | 01926500 | Cream - Topical | 0.025 % | 12/31/1989 |
| ALTRENO | bausch health, canada inc. | 02510243 | Lotion - Topical | 0.05 % / W/W | N/A |
| STIEVA-A SOLUTION | 00578568 | Solution - Topical | 0.025 % | 12/31/1983 | |
| RETIN-A MICRO | bausch health, canada inc. | 02264633 | Gel - Topical | 0.04 % / W/W | 8/30/2005 |
| RETIN-A MICRO | bausch health, canada inc. | 02243914 | Gel - Topical | 0.1 % / W/W | 8/1/2001 |
| RETISOL-A | 02008718 | Cream - Topical | 0.05 % | 12/31/1993 | |
| BIACNA TOPICAL GEL | bausch health, canada inc. | 02359685 | Gel - Topical | 0.025 % / W/W | 5/16/2011 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TRECLINAC 10 MG/G + 0,25 MG/G GEL | Viatris As | 118356IP | GEL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| NEOCARE 4 mg/g CREMA | Industrial Farmaceutica Cantabria S.A. | 52751 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| RETIRIDES 0,5 MG/G CREMA | Galenicum Derma S.L.U. | 60141 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| RETIRIDES 1 MG/G CREMA | Galenicum Derma S.L.U. | 60142 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| RETIRIDES 0,25 MG/G CREMA | Galenicum Derma S.L.U. | 60140 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TRECLINAC 10 MG/G + 0,25 MG/G GEL | 77481 | GEL | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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