Isotretinoin

Generic Name: Isotretinoin

Brand Names: Absorica, Accutane, Amnesteem, Claravis, Clarus, Epuris, Myorisan, Sotret, Zenatane

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₈O_₂

CAS Number: 4759-48-2

Unique Ingredient Identifier: EH28UP18IF

Background: 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

Isotretinoin, Interferon Alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Phase 3

Completed

Conditions: Head and Neck Cancer

First Posted Date: 2003-02-06

Last Posted Date: 2023-06-15

Lead Sponsor: Eastern Cooperative Oncology Group

Registration Number: NCT00054561

Locations: 🇺🇸
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
🇺🇸
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
🇺🇸
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

and more 86 locations

Multiple Therapies in Treating Patients With Advanced Neuroblastoma

Phase 2

Completed

Conditions: Neuroblastoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-03-07

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00040872

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Combination Chemotherapy With or Without Filgrastim Before Surgery, High-Dose Chemotherapy, and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma

Phase 3

Conditions: Neuroblastoma

First Posted Date: 2003-01-27

Last Posted Date: 2014-06-24

Lead Sponsor: University of Leicester

Target Recruit Count: 175

Registration Number: NCT00030719

Locations: 🇧🇪
Universitair Ziekenhuis Gent, Ghent, Belgium
🇳🇴
Rikshospitalet University Hospital, Oslo, Norway
🇬🇧
Birmingham Children's Hospital, Birmingham, England, United Kingdom

and more 28 locations

Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Phase 2

Completed

Conditions: Prostate Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2023-06-22

Lead Sponsor: Eastern Cooperative Oncology Group

Registration Number: NCT00005847

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Ireland Cancer Center, Cleveland, Ohio, United States
🇺🇸
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States

and more 16 locations

Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma

Phase 2

Completed

Conditions: Neuroblastoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-10-31

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00004110

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma

Phase 3

Completed

Conditions: Neuroblastoma

Interventions: Biological: filgrastim
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: isotretinoin
Drug: melphalan
Drug: topotecan hydrochloride
Drug: vincristine sulfate
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy

First Posted Date: 2003-01-27

Last Posted Date: 2013-05-17

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 495

Registration Number: NCT00004188

Locations: 🇺🇸
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
🇺🇸
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

and more 93 locations

Combination Chemotherapy Followed By Donor Bone Marrow or Umbilical Cord Blood Transplant in Treating Children With Newly Diagnosed Juvenile Myelomonocytic Leukemia

Phase 2

Completed

Conditions: Juvenile Myelomonocytic Leukemia

Interventions: Drug: tipifarnib
Drug: isotretinoin
Drug: fludarabine phosphate
Drug: cytarabine
Radiation: radiation therapy
Drug: cyclophosphamide
Biological: anti-thymocyte globulin
Procedure: allogeneic bone marrow transplantation
Procedure: double-unit umbilical cord blood transplantation
Procedure: umbilical cord blood transplantation
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-04-11

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 100

Registration Number: NCT00025038

Locations: 🇺🇸
Children's Oncology Group, Arcadia, California, United States

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

Phase 3

Active, not recruiting

Conditions: Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4S Neuroblastoma
Stage 4 Neuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma

Interventions: Drug: Isotretinoin
Biological: Aldesleukin
Other: Laboratory Biomarker Analysis
Biological: Dinutuximab
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Biological: Sargramostim

First Posted Date: 2003-01-27

Last Posted Date: 2025-04-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1449

Registration Number: NCT00026312

Locations: 🇺🇸
AdventHealth Orlando, Orlando, Florida, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Providence Alaska Medical Center, Anchorage, Alaska, United States

and more 194 locations

Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies

Phase 2

Completed

Conditions: Lymphoma, T-Cell
Hematologic Neoplasms
Mycosis Fungoides

Interventions: Drug: Isotretinoin (Accutane)
Drug: Interferon Alpha

First Posted Date: 2002-05-31

Last Posted Date: 2018-10-29

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 56

Registration Number: NCT00038376

Locations: 🇺🇸
M. D. Anderson Cancer Center, Houston, Texas, United States

Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors

Phase 3

Completed

Conditions: Cervix, Dysplasia
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-11-04

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 150

Registration Number: NCT00001073

Locations: 🇺🇸
Bmc Actg Crs, Boston, Massachusetts, United States
🇺🇸
Hosp. of the Univ. of Pennsylvania CRS, Philadelphia, Pennsylvania, United States
🇺🇸
UW School of Medicine - CHRMC, Seattle, Washington, United States

and more 37 locations

Drug Development Updates

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