Overview
Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne. It was most widely marketed under the brand name Accutane, which has since been discontinued. Isotretinoin is associated with major risks in pregnancy and is therefore only available under the iPLEDGE program in the United States. The first isotretinoin-containing product was FDA approved on 7 May 1982.
Indication
Isotretinoin is indicated to treat severe recalcitrant nodular acne and patients ≥12 years enrolled in the iPLEDGE program.
Associated Conditions
- Acne conglobata
- Neuroblastoma (NB)
- Rosacea
- Sezary Syndrome
- Early Mycosis Fungoides (MF)
- Refractory Acne vulgaris
- Severe Recalcitrant nodular acne
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/08 | Not Applicable | Recruiting | |||
2025/04/24 | Early Phase 1 | Not yet recruiting | C17 Council | ||
2025/03/12 | Phase 4 | Completed | SB Istanbul Education and Research Hospital | ||
2024/11/20 | Phase 4 | Not yet recruiting | University Hospital, Strasbourg, France | ||
2024/07/03 | Phase 1 | Not yet recruiting | |||
2024/06/11 | Phase 3 | Completed | |||
2024/06/07 | Phase 3 | Recruiting | |||
2024/04/23 | Not Applicable | Recruiting | |||
2024/02/05 | Phase 3 | Completed | Mostafa Bahaa | ||
2024/01/26 | Early Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-6308 | ORAL | 40 mg in 1 1 | 1/20/2014 | |
| JG Pharma Inc. | 72143-253 | ORAL | 30 mg in 1 1 | 11/10/2022 | |
| Sun Pharmaceutical Industries, Inc. | 57664-024 | ORAL | 35 mg in 1 1 | 1/10/2024 | |
| Aurobindo Pharma Limited | 59651-633 | ORAL | 25 mg in 1 1 | 1/31/2024 | |
| Mylan Pharmaceuticals Inc. | 0378-6614 | ORAL | 40 mg in 1 1 | 11/23/2021 | |
| Galephar Pharmaceutical Research Inc. | 66277-339 | ORAL | 30 mg in 1 1 | 1/29/2022 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1025 | ORAL | 40 mg in 1 1 | 9/1/2023 | |
| Amneal Pharmaceuticals NY LLC | 69238-1176 | ORAL | 40 mg in 1 1 | 12/30/2023 | |
| Sun Pharmaceutical Industries, Inc. | 57664-025 | ORAL | 40 mg in 1 1 | 1/10/2024 | |
| Upsher-Smith Laboratories, LLC | 0832-8304 | ORAL | 40 mg in 1 1 | 6/8/2023 |
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 |
|---|---|---|---|---|---|
| ROACCUTANE CAPSULE 20 mg | SIN04921P | CAPSULE, LIQUID FILLED | 20 mg | 7/10/1990 | |
| NIMEGEN SOFT CAP. 10 mg | SIN10767P | CAPSULE, LIQUID FILLED | 10 mg | 2/23/1999 | |
| ORATANE CAPSULE 10 mg | SIN11782P | CAPSULE | 10 mg | 1/23/2002 | |
| ROACCUTANE CAPSULE 10 mg | SIN04920P | CAPSULE, LIQUID FILLED | 10 mg | 7/10/1990 | |
| ORATANE CAPSULE 5 mg | SIN14628P | CAPSULE | 5MG | 9/22/2014 | |
| ACNOTIN 10 | SIN13333P | CAPSULE | 10MG | 8/8/2007 | |
| ORATANE CAPSULE 20 mg | SIN11781P | CAPSULE | 20.00mg | 1/23/2002 | |
| ACNOTIN 20 | SIN13051P | CAPSULE | 20 mg | 3/4/2005 |
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 |
|---|---|---|---|---|---|
| ROACCUTANE CAP 20MG | N/A | N/A | N/A | 1/31/1984 | |
| ROACCUTANE CAP 10MG | N/A | N/A | N/A | 1/31/1984 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ISOTRETINOIN-AS isotretinoin 40mg capsule blister pack | 186329 | Medicine | A | 6/8/2012 | |
| ISOTRETINOIN-AS isotretinoin 10mg capsule - soft blister pack | 186327 | Medicine | A | 6/8/2012 | |
| APO-ISOTRETINOIN isotretinoin 10mg capsule - soft blister pack | 190940 | Medicine | A | 12/15/2011 | |
| DERMATANE isotretinoin 10mg capsule blister pack | 144129 | Medicine | A | 1/8/2008 | |
| ISOTRETINOIN ASCENT isotretinoin 5mg capsule blister pack | 186334 | Medicine | A | 6/8/2012 | |
| ORATANE isotretinoin 40mg capsule blister pack | 117206 | Medicine | A | 7/5/2006 | |
| ISOTRETINOIN-AS isotretinoin 20mg capsule blister pack | 186328 | Medicine | A | 6/8/2012 | |
| ISOTRETINOIN ASCENT isotretinoin 10mg capsule - soft blister pack | 186335 | Medicine | A | 6/8/2012 | |
| DERMATANE isotretinoin 40mg capsule blister pack | 186345 | Medicine | A | 6/8/2012 | |
| ISOTRETINOIN LUPIN isotretinoin10 mg capsule blister pack | 324225 | Medicine | A | 12/2/2019 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CLARUS | Mylan Pharmaceuticals ULC | 02257955 | Capsule - Oral | 10 MG | 4/1/2005 |
| EPURIS | 02396971 | Capsule - Oral | 10 MG | 5/7/2013 | |
| EPURIS | 02397013 | Capsule - Oral | 40 MG | 5/7/2013 | |
| ABSORICA LD | 02539063 | Capsule - Oral | 24 MG | 9/26/2023 | |
| RAN-ISOTRETINOIN | ranbaxy pharmaceuticals canada inc. | 02309173 | Capsule - Oral | 10 MG | N/A |
| EPURIS | 02397005 | Capsule - Oral | 30 MG | 5/7/2013 | |
| ABSORICA LD | 02539055 | Capsule - Oral | 16 MG | 9/26/2023 | |
| ACCUTANE ROCHE | Hoffmann-La Roche Limited | 00582352 | Capsule - Oral | 40 MG | 12/31/1983 |
| EPURIS | 02396998 | Capsule - Oral | 20 MG | 5/7/2013 | |
| ABSORICA LD | 02539071 | Capsule - Oral | 32 MG | 9/26/2023 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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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