ALTRENO (tretinoin)
Altreno is a topical retinoid lotion used for acne vulgaris in patients 9 years of age and older. This medication helps patients with skin breakouts by targeting the underlying cellular processes that cause acne to form. As a vitamin A derivative, it helps clear existing lesions and prevents the development of new ones.
How ALTRENO Works
This drug works by binding to specific retinoic acid receptors to modify gene expression and epithelial cell growth. It helps clear acne by decreasing the stickiness of skin cells to prevent new clogs from forming. Additionally, it increases cell turnover, which helps the skin shed existing comedones.
Details
- Status
- Prescription
- First Approved
- 2018-08-23
- Patent Cliff
- 2038
- Routes
- TOPICAL
- Dosage Forms
- LOTION
ALTRENO Approval History
What ALTRENO Treats
1 indicationsALTRENO is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acne Vulgaris
ALTRENO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ALTRENO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 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 |
| NCT04548349 results posted | 2020P000595 | Ph 4 | completed | Profiling the Skin Microbiome in Response to Altreno in Acne Patients |
| 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.
ALTRENO FDA Label Details
Indications & Usage
FDA Label (PDF)ALTRENO is indicated for the treatment of Acne Vulgaris.
ALTRENO Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for ALTRENO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.