Drugs / Isotretinoin
Isotretinoin
English name isotretinoin
also known as
13-cis retinoic acid · 13-cis-RA · Accutane · ISO · Roaccutane · 13-CRA · CIP-Isotretinoin · NSC-329481 · +1 more
Other / unclassified targets ACE2, CYP2D6, TMPRSS2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ACCUTANE | — | 1986-06-06 – 2002-05-02 | fda.gov ↗ |
| Approved | US (FDA) | ACCUTANE | — | 1982-05-07 | fda.gov ↗ |
Trials 93 · started per year
today
US approved 1982
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT06942039 | Sep 2025 → Dec 2030 expected | atypical teratoid rhabdoid tumor, childhood medulloblastoma, embryonal tumor with multilayered rosettes, ependymoblastoma +5 | C17 Council | Recruiting | No outcome recorded |
| Phase 0 | NCT06225570 | Feb 2025 → Mar 2027 expected | acne | Medical University of South Carolina | Recruiting | No outcome recorded |
| Phase 0 | NCT02620813 | Oct 2015 → Oct 2017 | acne | University of California, Davis | Completed | No outcome recorded |
| Phase 116 trials | ||||||
| Phase 1 | NCT06485505 | Jul 2024 → Jul 2026 overdue | tinea unguium | Zagazig University | Recruiting | No outcome recorded |
| Phase 1 | NCT06201624 | Mar 2023 → Jan 2024 | hyperpigmentation of the skin | Zagazig University | Unknown | No outcome recorded |
| Phase 1 | NCT04382950 | Jul → Aug 2021 | COVID-19 | Kafrelsheikh University | Unknown | No outcome recorded |
| Phase 1 | NCT01711554 | Feb 2013 → Sep 2018 overdue | neuroblastoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01175356 | Dec 2011 → Sep 2016 | ganglioneuroblastoma, neuroblastoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1 | NCT01888224 | Jun 2011 | — | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 1 | NCT01319838 | Mar 2011 → Dec 2013 | neuroblastoma | Emory University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01208454 | Dec 2010 → Sep 2014 | neuroblastoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01103375 | May 2010 → Jan 2013 | adult glioblastoma, adult oligodendroglioma, anaplastic astrocytoma, anaplastic oligodendroglioma +3 | Wake Forest University Health Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00867178 | Feb 2009 → Apr 2020 | medulloblastoma, pineoblastoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00334789 | Jun 2006 → Mar 2018 | neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00416585 | Oct 2005 → Nov 2006 | acne | Shahid Beheshti University of Medical Sciences | Completed | No outcome recorded |
| Phase 1 | NCT00217412 | Aug 2005 → Sep 2009 | Burkitt lymphoma, Hodgkins lymphoma, acute promyelocytic leukemia, atypical teratoid rhabdoid tumor +9 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00005576 | Jan 2001 → Mar 2002 | neuroblastoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00014729 | Oct 2000 → Sep 2002 | epidermolysis bullosa dystrophica | University of North Carolina | Completed | No outcome recorded |
| Phase 1 | NCT00000764 | ? → Jul 1996 | HIV infectious disease, anus neoplasm | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT04730895 | Jul → Sep 2021 | — | Kafrelsheikh University | Unknown | No outcome recorded |
| Phase 1/2 | NCT04594759 | Nov 2020 → Dec 2021 | acne | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 1/2 | NCT01560585 | Apr 2012 → Aug 2014 | Alzheimer disease | University Hospitals Cleveland Medical Center | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT00555399 | Nov 2007 → Jan 2020 | glioblastoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT00324740 | Mar 2006 → Feb 2011 | renal cell carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1/2 | NCT00003619 | Feb 1998 → Apr 2004 | leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, thrombocytopenia | Drexel University College of Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT00003585 | Aug 1996 → Aug 2001 | kidney cancer | University of New Mexico | Completed | No outcome recorded |
| Phase 225 trials · 1 missed | ||||||
| Phase 2 | NCT07629167 | Aug 2026 → Aug 2029 expected | acneiform dermatitis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07481370 | Apr 2026 → Jun 2027 expected | azoospermia, oligospermia | University of Nebraska | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT04909515 | Dec 2021 → Jun 2026 | neuroblastoma | Y-mAbs Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04385277 | Dec 2020 → Jun 2023 overdue | neuroblastoma, nodular ganglioneuroblastoma | Children's Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04154293 | Dec 2019 → Aug 2021 | inherited ichthyosis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT04870489 | Nov 2017 → Nov 2020 | acne | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02864082 | Mar 2017 → Feb 2018 | inherited ichthyosis | Patagonia Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 2 | NCT03033303 | Jan 2017 → Sep 2025 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02771743 | Apr 2015 → Mar 2020 | neuroblastoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02169609 | Nov 2014 → Dec 2016 | neuroblastoma | Fundació Sant Joan de Déu | Completed | No outcome recorded |
| Phase 2 | NCT01334515 | Sep 2011 → Dec 2013 | neuroblastoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00112502 | Sep 2005 → Sep 2014 | glioblastoma | M.D. Anderson Cancer Center | Completed | Missed primary |
| Phase 2 | NCT00098020 | Nov 2004 → Jun 2016 | focal segmental glomerulosclerosis | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT00089258 | Jul 2004 → Nov 2006 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00176527 | Nov 2002 → Aug 2007 | prostate cancer | University of Medicine and Dentistry of New Jersey | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00025038 | Jun 2001 → Oct 2007 | juvenile myelomonocytic leukemia | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00005847 | Apr 2001 → Jul 2004 | prostate cancer | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00017368 | Apr 2001 → Sep 2005 | neuroblastoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00138151 | Mar 2001 → Nov 2010 | cervical cancer | University of Medicine and Dentistry of New Jersey | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00040872 | Jun 2000 → Jan 2007 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00021359 | Aug 1999 → Jul 2000 | plasma cell myeloma | Fox Chase Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00004110 | Aug 1999 → Sep 2004 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00003405 | Apr 1998 → Apr 1999 | leukemia | Rush University Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00002506 | Aug 1992 → Jan 1996 | cervical cancer, esophageal cancer, head and neck cancer, lung cancer +2 | Hoag Memorial Hospital Presbyterian | Completed | No outcome recorded |
| Phase 2 | NCT00038376 | May 1990 → Jun 2005 | mycosis fungoides | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 317 trials · 3 met primary · 2 missed | ||||||
| Phase 3 | NCT06447480 | Apr 2025 → Sep 2027 expected | acne | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| Phase 3 | NCT04290572 | Mar 2020 → Feb 2023 | common wart | Centro Dermatológico Dr. Ladislao de la Pascua | Unknown | No outcome recorded |
| Phase 3 | NCT01041638 | Dec 2009 → Dec 2013 | neuroblastoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT00975143 | Sep 2009 → May 2011 | acne | Cipher Pharmaceuticals Inc. | Completed | Met primary |
| Phase 3 | NCT00499616 | Oct 2007 → Jun 2014 | neuroblastoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00392327 | May 2007 → Jun 2019 | anaplastic/large cell medulloblastoma | Children's Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00882531 | Feb 2007 → Aug 2009 | rosacea | Laboratoires Bailleul-Biorga | Completed | No outcome recorded |
| Phase 3 | NCT00410631 | Oct 2004 → Dec 2010 | neuroblastoma | German Society for Pediatric Oncology and Hematology GPOH gGmbH | Unknown | No outcome recorded |
| Phase 3 | NCT00078988 | Oct 2004 → Sep 2006 | brain neoplasm | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00054561 | Nov 2003 → Dec 2004 | head and neck cancer | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00030719 | Dec 2001 → ? | neuroblastoma | University of Leicester | Unknown | Met primary |
| Phase 3 | NCT00026312 | Oct 2001 → Jan 2012 | neuroblastoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT00004188 | Feb 2001 → Oct 2007 | neuroblastoma | Children's Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00002737 | Mar 1996 → Jan 2001 | kidney cancer | European Organisation for Research and Treatment of Cancer - EORTC | Completed | Met primary |
| Phase 3 | NCT00003564 | — | central nervous system cancer | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT00003599 | — | lung cancer | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT00001073 | ? → Mar 2001 | HIV infectious disease, dysplasia of cervix | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT07675239 | Oct 2026 → Mar 2027 expected | tinea corporis | Pak Emirates Military Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07639073 | Jul → Oct 2026 expected | acne | Pakistan Institute of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06698263 | Mar 2025 → Dec 2027 expected | male infertility | University Hospital, Strasbourg, France | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07012811 | Feb 2024 → Mar 2025 | skin disorder caused by infection | Latakia University | Completed | No outcome recorded |
| Phase 4 | NCT06047535 | Oct 2023 → Jun 2027 expected | neuroblastoma | SciClone Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06873087 | Sep 2023 → Jun 2024 | rosacea | SB Istanbul Education and Research Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05666765 | Jan → Nov 2023 | acne | Tanta University | Unknown | No outcome recorded |
| Phase 4 | NCT04940767 | Jun 2021 → Apr 2023 | acne | Edward Lain, MD | Completed | No outcome recorded |
| Phase 4 | NCT03076021 | Jul 2016 → Nov 2023 | — | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT02457520 | Jan 2015 → Apr 2018 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01445028 | Sep 2011 → Aug 2013 | proliferative vitreoretinopathy | Wills Eye | Completed | No outcome recorded |
| Phase 4 | NCT01404130 | Sep 2008 → Nov 2010 | acne | University of Aberdeen | Completed | No outcome recorded |
| Phase 4 | NCT07228481 | Jun 2001 → Mar 2025 | acne | Premier Specialists, Australia | Completed | No outcome recorded |
| Phase not applicable12 trials | ||||||
| — | NCT07142070 | Sep → Dec 2025 overdue | periodontal disorder | Medipol University | Not yet recruiting | No outcome recorded |
| — | NCT07309341 | Jun 2025 → Jul 2026 | anosmia | Uşak University | Completed | No outcome recorded |
| — | NCT07420894 | Jan → Jul 2025 | dermatophytosis | Multan Medical And Dental College | Completed | No outcome recorded |
| — | NCT07675460 | Apr 2024 → Jul 2025 | acne, dry eye syndrome | Demet Mutlu | Completed | No outcome recorded |
| — | NCT06378983 | Sep 2022 → Jun 2024 | acne | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| — | NCT05622253 | Mar → Dec 2022 | acne | Zagazig University | Completed | No outcome recorded |
| — | NCT04204304 | Mar → Aug 2019 | isotretinoin syndrome, musculoskeletal system disorder, vitamin D deficiency | Ankara Training and Research Hospital | Completed | No outcome recorded |
| — | NCT02795143 | Nov 2016 → Jun 2020 | toxic epidermal necrolysis | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT02100930 | Mar 2014 → Mar 2019 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| — | NCT00939965 | Feb 2009 → ? | neuroblastoma | Children's Cancer and Leukaemia Group | Unknown | No outcome recorded |
| — | NCT00526318 | Jan 2007 → Dec 2016 | neuroblastoma | German Society for Pediatric Oncology and Hematology GPOH gGmbH | Unknown | No outcome recorded |
| — | NCT00025012 | Jun 1991 → Feb 2004 | cutaneous melanoma | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Comparator or background therapy37 trials | ||||||
| Phase 1 | NCT00098891 Background | Oct 2004 → Mar 2008 | Burkitt lymphoma, Hodgkins lymphoma, MALT lymphoma, Waldenstrom macroglobulinemia +13 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00070200 Background | Mar 2004 → Sep 2006 | neuroblastoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1 | NCT01020539 Background | Sep 2002 → Jul 2011 | acute myeloid leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome | Columbia University | Completed | No outcome recorded |
| Phase 1/2 | NCT01592045 Background | Aug 2012 → Jun 2014 | neuroblastoma | United Therapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT01701479 Background | Jan 2012 → Dec 2020 | neuroblastoma | St. Anna Children's Cancer Research | Unknown | No outcome recorded |
| Phase 1/2 | NCT00609739 Background | Jun 1999 → Jun 2010 | leukemia | Masonic Cancer Center, University of Minnesota | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05684861 Comparator | Jan → Dec 2022 | acne | South Valley University | Completed | No outcome recorded |
| Phase 2 | NCT04389580 Comparator | Sep → Oct 2021 | COVID-19 | Kafrelsheikh University | Unknown | No outcome recorded |
| Phase 2 | NCT04577378 Comparator | Oct → Nov 2020 | COVID-19 | Kafrelsheikh University | Unknown | No outcome recorded |
| Phase 2 | NCT04396067 Comparator | Oct 2020 | COVID-19 | Kafrelsheikh University | Unknown | No outcome recorded |
| Phase 2 | NCT03471455 Comparator | Apr 2018 → Jan 2019 | tinea infection | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 2 | NCT01969058 Comparator | Jul 2014 → Aug 2016 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 2 | NCT01857934 Background | Jul 2013 → Oct 2021 | neuroblastoma | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02278861 Comparator | Nov 2011 → Apr 2014 | actinic keratosis | Federal University of Goiás | Completed | No outcome recorded |
| Phase 2 | NCT00842907 Comparator | May → Dec 2009 | radiation-induced disorder | Federal University of São Paulo | Unknown | No outcome recorded |
| Phase 2 | NCT00701740 Comparator | Jul 2007 → Jan 2008 | — | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 3 | NCT06172296 Background | Apr 2024 → Dec 2029 expected | neuroblastoma, nodular ganglioneuroblastoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT06242288 Comparator | Jan 2024 → Jan 2025 | acne | Mostafa Bahaa | Completed | No outcome recorded |
| Phase 3 | NCT04353180 Comparator | Aug → Oct 2021 | COVID-19 | Kafrelsheikh University | Unknown | No outcome recorded |
| Phase 3 | NCT04361422 Comparator | Dec 2020 → Aug 2021 | COVID-19 | Tanta University | Unknown | No outcome recorded |
| Phase 3 | NCT03126916 Background | May 2018 → Sep 2030 expected | neuroblastoma, nodular ganglioneuroblastoma | Children's Oncology Group | Recruiting | No outcome recorded |
| Phase 3 | NCT06451237 Comparator | Jan 2018 → Dec 2022 | acne | Alexandria University | Completed | No outcome recorded |
| Phase 3 | NCT01474590 Comparator | Nov 2011 → Jul 2013 | acne | Galderma R&D | Completed | Met primary |
| Phase 3 | NCT00567567 Background | Nov 2007 → Feb 2015 | neuroblastoma | Children's Oncology Group | Completed | Mixed |
| Phase 3 | NCT03042429 Comparator | Jan 2007 → Dec 2016 | neuroblastoma | University of Cologne | Completed | Met primary |
| Phase 4 | NCT05316675 Comparator | Dec 2022 → Oct 2024 | acne | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT04864717 Comparator | Sep 2021 → Dec 2022 | acneiform dermatitis, cancer-related condition | Lady Davis Institute | Unknown | No outcome recorded |
| Phase 4 | NCT05218486 Comparator | Aug 2021 → Sep 2022 | acne | Alshimaa Abbas Mohamed Ebrahim | Unknown | No outcome recorded |
| Phase 4 | NCT05529888 Comparator | Dec 2020 → Dec 2021 | acne | Aswan University | Completed | No outcome recorded |
| Phase 4 | NCT02855138 Comparator | Jan 2015 → Mar 2016 | — | Kayseri Education and Research Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01139749 Comparator | Oct 2011 → Jul 2012 | seborrheic dermatitis | Federal University of São Paulo | Unknown | No outcome recorded |
| — | NCT07054398 Comparator | Jan 2025 → Jan 2026 overdue | acne | Aswan University | Recruiting | No outcome recorded |
| — | NCT07753811 Comparator | Jan 2024 → Jan 2025 | acne, dry eye syndrome | Benha University | Completed | No outcome recorded |
| — | NCT05869188 Comparator | Jun → Dec 2023 | acne | South Valley University | Completed | No outcome recorded |
| — | NCT04167982 Comparator | Mar 2020 → Nov 2022 | acne | Shanghai Dermatology Hospital | Unknown | No outcome recorded |
| — | NCT03514771 Background | Jan 2016 → Mar 2017 | mixed dermis disorder | David Smart | Completed | No outcome recorded |
| — | NCT01526603 Background | Mar 2012 → May 2023 | neuroblastoma | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-10-02 | Cipher Pharmaceuticals Inc. | Regulatory EPURIS ® : Now Publicly Reimbursed in Alberta as a General Benefit cipherpharma.com ↗ |
| 2026-08-27 | Cipher Pharmaceuticals Inc. | Regulatory EPURIS ® : Now Publicly Reimbursed in Québec as a General Benefit cipherpharma.com ↗
Cipher Pharmaceuticals Inc. is pleased to inform you that EPURIS ® (isotretinoin) capsules have been approved for funding by the Government of Québec effective today August 27 th , 2026 1 . |
| 2026-08-17 | Cipher Pharmaceuticals Inc. | Regulatory EPURIS ® : Now Publicly Reimbursed in British Columbia as a General Benefit cipherpharma.com ↗
Cipher Pharmaceuticals Inc. is pleased to inform you that EPURIS ® (isotretinoin) capsules have been approved for funding by the Province of British Columbia effective today August 17 th , 2026 1 . |
| 2023-08-31 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg (RLD: Accutane® Capsules, 10 mg, 20 mg and 40 mg: RS: Claravis 10 mg, 20 mg, 30 mg and 40 mg). |
| 2018-02-01 | Impax Laboratories, LLC | Regulatory Amneal Introduces Isotretinoin Capsules amneal.com ↗
Amneal’s generic received FDA approval under a Risk Evaluation and Mitigation Strategy (REMS) known as the iPledge program. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-10-02 | Cipher Pharmaceuticals Inc. | EPURIS ® : Now Publicly Reimbursed in Alberta as a General Benefit cipherpharma.com ↗ |
| 2026-08-27 | Cipher Pharmaceuticals Inc. | EPURIS ® : Now Publicly Reimbursed in Québec as a General Benefit cipherpharma.com ↗ |
| 2026-08-17 | Cipher Pharmaceuticals Inc. | EPURIS ® : Now Publicly Reimbursed in British Columbia as a General Benefit cipherpharma.com ↗ |
| 2023-08-31 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg zyduslife.com ↗ |
| 2023-07-24 | Upsher-Smith Laboratories | Upsher-Smith Launches Isotretinoin Capsules, USP upsher-smith.com ↗ |
| 2018-02-01 | Impax Laboratories, LLC | Amneal Introduces Isotretinoin Capsules amneal.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 133 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | isotretinoin | “In another study by Sinha et al who analyzed a publicly available Connectivity Map (CMAP) dataset of pre/post transcriptomic profiles for drug treatment in cell lines for over...” NCT04382950 ↗129“After searching, we found a study analyzed a broad set of 672 clinically approved drugs for treatment in cell lines demonstrated that isotretinoin was the potent and strongest...” NCT04730895 ↗ “Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First...” NCT06047535 ↗ “Seconed drug is Isotretinoin(13cis RA) and ATRA may be able to inhibit COVID 2019 infection via inducing the antiviral immunity and this is discussed as follow :” NCT04396067 ↗ “Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin” NCT03042429 ↗ “Isotretinoin (13-cis-retinoic acid, or RA) (160mg/m2/day or 5.33mg/kg/day if \< 12kg) PO divided into 2 doses daily x 14 days.” NCT02169609 ↗ “Isotretinoin remains the mainstay of acne treatment.” NCT05622253 ↗ “Post-transplantation isotretinoin therapy” NCT00609739 ↗ “isotretinoin” NCT00701740 ↗ |
| Known as | 13-cis retinoic acid | “Subsequently, however, a sentinel randomized clinical trial demonstrated that isotretinoin(13-cis-retinoic acid), when given to patients with minimal residual disease following...” NCT01319838 ↗17“Isotretinoin (13-cis retinoic acid; 13-cis RA) is the only drug capable of inducing a long-term or permanent remission of acne; however, the mechanisms leading to this durable...” NCT04396067 ↗ “The most effective treatment for acne is still isotretinoin (13-cis-retinoic acid), an oral retinoid that was licensed in 1982 for the treatment of acne vulgaris.” NCT07054398 ↗ “Isotretinoin, also known as 13-cis-retinoic acid and sold under the brand name Accutane among others, is a medication primarily used to treat severe acne” NCT06242288 ↗ “Oral isotretinoin (13-cis-retinoic acid) is the only drug that counteracts all the pathogenetic mechanisms that contribute to the development of acne” NCT05218486 ↗ “Oral isotretinoin (13-cis-retinoic acid) is the only drug that counteracts all the pathogenetic mechanisms that contribute to the development of acne” NCT05529888 ↗ “Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.” NCT03076021 ↗ “Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:” NCT01592045 ↗ “isotretinoin (13-cis retinoic acid) is the most potent known inhibitor of sebum production.” NCT05869188 ↗ “Isotretinoin is a retinoic acid analogue (13-cis-retinoic acid) supplied as oral capsules.” NCT04940767 ↗ “controlled prospective study of oral isotretinoin (also called 13-cis retinoic acid)” PMID 3287161 ↗ Jun 1988 |
| Known as | 13-cis-RA | “Seconed drug is Isotretinoin(13cis RA) and ATRA may be able to inhibit COVID 2019 infection via inducing the antiviral immunity and this is discussed as follow :” NCT04396067 ↗4“Isotretinoin(13cis RA) may be able to inhibit COVID 2019 infection via reversIing the androgenic induction and activation effect of (DHT) on TMPRSS2 expression” NCT04353180 ↗ “Isotretinoin(13cis RA) may be able to inhibit COVID 2019 entry via down regulation of ACE2 via action like shRNA targeting ACE2 gene expression” NCT04382950 ↗ “Isotretinoin (13-cis retinoic acid (13-cis RA)) is the most potent inhibitor of sebum production” PMID 16575387 ↗ Mar 2006 “Isotretinoin(13cis RA) may be able to inhibit COVID 2019 entry via down regulation of ACE2” NCT04389580 ↗ |
| Known as | 13-CRA | “Isotretinoin, 13-CRA, NSC-329481; with Interferon alpha (Schering or Hoffmann-La Roche), IFN-A, NSC-377523 or NSC-367982.” NCT00002506 ↗ |
| Known as | Accutane | “Isotretinoin is a retinoic acid analogue (13-cis-retinoic acid) supplied as oral capsules. and was approved in the US for the treatment of severe acne vulgaris in 1982 under...” NCT04940767 ↗4“Isotretinoin, also known as 13-cis-retinoic acid and sold under the brand name Accutane among others, is a medication primarily used to treat severe acne” NCT06242288 ↗ “Isotretinoin (Accutane, Roche Laboratories Inc, Nutley, NJ) is an important drug” NCT04577378 ↗ “conventional course of isotretinoin (formerly known as Accutane)” NCT04594759 ↗ “Isotretinoin (Accutane)” NCT00038376 ↗ |
| Known as | CIP-Isotretinoin | “The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a marketed (generic) formulation of isotretinoin when both are administered twice daily...” NCT00975143 ↗ |
| Known as | ISO | “Isotretinoin (ISO) has been used in the treatment of patients with severe acne vulgaris (AV)” NCT04204304 ↗1“Oral isotretinoin (ISO) is the gold standard for severe nodular acne.” PMID 24934963 ↗ Oct 2014 |
| Known as | NSC-329481 | “Isotretinoin, 13-CRA, NSC-329481; with Interferon alpha (Schering or Hoffmann-La Roche), IFN-A, NSC-377523 or NSC-367982.” NCT00002506 ↗ |
| Known as | PAT-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02864082 ↗ |
| Known as | Roaccutane | “Oral administration of isotretinoin (Roaccutane) in capsule form” NCT07228481 ↗1“isotretinoin (Roaccutane)” NCT00416585 ↗ |
| Action | Inhibit | “Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.” NCT03076021 ↗ |
| Modality | Other / unclassified | “Oral isotretinoin is a retinoid” NCT01139749 ↗ |
| Route | Oral | “Patients are randomized to receive oral isotretinoin for 6 months or be observed only for 6 months” NCT00001073 ↗ |
| Target | CYP2D6 | “Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.” NCT03076021 ↗ |