ISOTRETINOIN
Isotretinoin is a retinoid indicated for non-pregnant patients 12 years of age and older for the treatment of severe recalcitrant nodular acne, defined as multiple inflammatory nodules with a diameter of 5 mm or greater. Due to the potential for significant adverse reactions, its use is reserved for cases unresponsive to conventional therapies, including systemic antibiotics. If a second course of therapy is required, a two-month waiting period is recommended, as skin condition may continue to improve after the initial 15 to 20-week course.
How ISOTRETINOIN Works
Isotretinoin is a retinoid that inhibits sebaceous gland function and keratinization. It reduces sebaceous gland size and inhibits differentiation, leading to a dose-related, temporary decrease in sebum secretion. While the exact biological mechanism in treating severe recalcitrant nodular acne is not fully understood, clinical improvement is closely associated with the reduction in sebum production.
Details
- Status
- Prescription
- First Approved
- 2017-09-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ISOTRETINOIN Approval History
What ISOTRETINOIN Treats
1 indicationsISOTRETINOIN is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acne
ISOTRETINOIN Boxed Warning
EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY Isotretinoin capsules can cause severe life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of isotretinoin capsules even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affecte...
WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY Isotretinoin capsules can cause severe life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of isotretinoin capsules even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. If pregnancy occurs, discontinue isotretinoin capsules immediately and refer the patient to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ] . Because of the risk of embryo-fetal toxicity, isotretinoin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS [see Warnings and Precautions (5.2) ] . WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY See full prescribing information for complete boxed warning. Isotretinoin capsules can cause life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. ( 4 , 5.1 , 8.1 ) Isotretinoin capsules are available only through a restricted program called the iPLEDGE REMS. ( 5.2 )
ISOTRETINOIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 ISOTRETINOIN
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
33 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06172296 | NCI-2023-08530 NCI-2023-08530, ANBL2131 | Ph 3 | recruiting | Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma |
| NCT07481370 | 0849-25-FB | Ph 2 | enrolling by invitation | Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm |
| NCT01857934 results posted | NB2012 NCI-2013-00034 | Ph 2 | completed | Therapy for Children With Advanced Stage Neuroblastoma |
| NCT01711554 | NCI-2012-02011 NCI-2012-02011, CDR0000741991 | Ph 1 | active not recruiting | Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma |
| NCT03786783 results posted | NCI-2018-03732 NCI-2018-03732, ANBL17P1 | Ph 2 | active not recruiting | Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma |
| NCT03126916 | ANBL1531 NCI-2016-01734, ANBL1531 | Ph 3 | recruiting | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) |
| NCT01175356 results posted | ANBL09P1 NCI-2011-01745, ANBL09P1 | Ph 1 | completed | Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin |
| NCT04385277 results posted | ANBL19P1 NCI-2020-02950, ANBL19P1 | Ph 2 | active not recruiting | Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) |
| NCT03033303 | 16-1643 | Ph 2 | completed | A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma |
| NCT03076021 results posted | STUDY00002324 R01GM124264 | Ph 4 | completed | Effects of Isotretinoin on CYP2D6 Activity |
| NCT06698263 ARESPERM | 7345 2024-519644-33-00 | Ph 4 | not yet recruiting | 13-cis Retinoic Acid (Isotretinoin) and Sperm Production |
| NCT01969058 results posted | ACTG A5325 UM1AI068636 | Ph 2 | completed | Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery |
| NCT04940767 | V77-123 | Ph 4 | completed | A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris |
| NCT05684861 | SVU MED DVA021 4 22 11 508 | Ph 2 | completed | Serum TWEAK Levels in Acne Vulgaris |
| NCT05529888 | 322/1/19 | Ph 4 | completed | Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin. |
| NCT04909515 | 202 | Ph 2 | withdrawn | Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission. |
| NCT04154293 results posted | 235-9051-202 1R01FD006079-01A1 | Ph 2 | completed | A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis |
| NCT01560585 results posted | ISOTRT-01 | Ph 1, Ph 2 | terminated | Open Label Study of Isotretinoin in Mild to Moderate Alzheimer's Disease |
| NCT04594759 WIT results posted | 00103493 | Ph 1, Ph 2 | completed | Weekly Isotretinoin Therapy Study |
| NCT00867178 | NCI-2012-03167 NCI-2012-03167, PBTC-026 | Ph 1 | completed | Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System |
| NCT01041638 results posted | NCI-2011-01997 NCI-2011-01997, COG-ANBL0931 | Ph 3 | completed | Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma |
| NCT02457520 results posted | ABS157LT | Ph 4 | completed | ABSORICA in Patients With Severe Recalcitrant Nodular Acne |
| NCT01474590 POWER results posted | RD.03.SPR.29099 | Ph 3 | completed | Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne |
| NCT01334515 results posted | ANBL1021 NCI-2011-02672, CDR0000698589 | Ph 2 | completed | Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma |
| NCT01103375 | IRB00012306 NCI-2010-00132, CCCWFU 91209 | Ph 1 | terminated | Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma |
| NCT01445028 DELIVER results posted | WEI-DELIVER | Ph 4 | completed | Isotretinoin for Proliferative Vitreoretinopathy |
| NCT01208454 | NCI-2011-02522 NCI-2011-02522, N2008-02 | Ph 1 | completed | Vorinostat and Isotretinoin in Treating Patients With High-Risk Refractory or Recurrent Neuroblastoma |
| NCT01592045 results posted | DIV-NB-201 | Ph 1, Ph 2 | completed | ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma |
| NCT00975143 results posted | ISOCT.08.01 | Ph 3 | completed | Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne |
| NCT01319838 Aflac ST1001 | IRB00047148 Aflac ST1001 | Ph 1 | withdrawn | Aflac ST1001 Prolonged Isotretinoin |
| NCT01888224 | 618-10 | Ph 1 | completed | Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition |
| NCT01861626 | V00057 CA 1 01 2013-000988-80 | Ph 1 | completed | Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects |
| NCT01404130 | 07/S0802/135 | Ph 4 | completed | A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory |
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.
ISOTRETINOIN FDA Label Details
Indications & Usage
ISOTRETINOIN is indicated for the treatment of Acne.
WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY Isotretinoin capsules can cause severe life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of isot...
Looking for the branded version?
ABSORICA
Full clinical data, patents, trials, and competitive landscape for isotretinoin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.