Product Description
Tretinoin (all-trans-retinoic acid) is a retinol (vitamin A) derivative which has been evaluated as a topical treatment for the symptoms of photodamaged skin. In several well-controlled clinical trials, the proportion of patients showing improvement was significantly higher with 0.01 or 0.05% tretinoin cream than with placebo for criteria such as global assessment, fine and coarse wrinkling, pigmentation and roughness.Ê (Sourced from: https://pubmed.ncbi.nlm.nih.gov/7663068/)
Mechanisms of Action: RAR Binder
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Topical,Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | India | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Acne Vulgaris | Acne Vulgaris | Acne Vulgaris | Acne Vulgaris | Acne Vulgaris
Known Adverse Events: Pain Unspecified | Erythema | Pharyngitis | Pruritus | Nasopharyngitis | Sinusitis | Sunburn | Dermatitis
Company: Bausch Health Americas
Company Location: QUEBEC A8 H7L 4A8
Company CEO: Thomas J. Appio
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, Germany, Spain, United Kingdom, United States
Active Clinical Trial Count: 14
Highest Development Phases
Phase 3: Acne Vulgaris|Other
Phase 2: Astrocytoma|Breast Cancer|Chronic Lymphoid Leukemia|Colorectal Cancer|Diffuse Large B-Cell Lymphoma|Leukemia, Plasma Cell|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell|Melanoma|Multiple Myeloma|Oligodendroglioma|Pancreatic Cancer
Phase 1: Oncology Solid Tumor Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ATRA | P2 |
Recruiting |
Multiple Myeloma |
2029-07-01 |
|
| STARPAC2 | P2 |
Active, not recruiting |
Pancreatic Cancer |
2028-06-29 |
|
| 2021-003993-30 | P2 |
Active, not recruiting |
Chronic Lymphoid Leukemia|Multiple Myeloma|Diffuse Large B-Cell Lymphoma |
2026-10-28 |
|
| STU-2023-0409 | P2 |
Recruiting |
Colorectal Cancer |
2026-10-01 |