Accutane
(Isotretinoin)ApprovedSmall molecule
Isotretinoin is used to treat severe acne that hasn't responded to other treatments. It's a very strong medication that can permanently clear severe acne, but it requires careful monitoring because it can cause serious side effects.[2] Accutane is currently approved and in use across 46 indications[4].[1]
Accutane is one of 906 small molecule programs targeting Glioma. It is currently in Approved.
46
Indications
119
Total Trials
17
Active Trials
905
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 46 indications
Competition
Competitive Landscape
1931 competitors in COVID-19
#DrugCompanyPhaseTrials
1Accutane
CConrado Roberto Hoffmann Filho
Approved
COVID-19 Vaccine
ModernaPreclinical
Biaxin
AbbViePreclinical
Singulair
AstraZenecaPreclinical
Calciferol
Alnylam PharmaceuticalsPreclinical
Benadryl
PParkedale
Preclinical
Low-Molecular-Weight Heparin
Daiichi SankyoPreclinical
Nadroparin
GSKPreclinical
Selenium
SSWOG Cancer Research Network
Preclinical
Blood Collection
AAssistance Publique - Hôpitaux de Paris
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Neuroblastoma28 trials
Show 25 more trials
Acne Vulgaris8 trials
Assessment of Serum Catestatin Level in Acne Vulgaris Patients
Recruiting·—·N/A·NCT07054398·60 enrolled
A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris
Completed·—·Phase 4·NCT04940767·31 enrolled
Show 5 more trials
Acne4 trials
Efficacy and Safety4 trials
Show 1 more trial
Kidney Cancer3 trials
Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002737·320 enrolled
56 more indications
Leukemia3 trials
Treatment3 trials
Oral2 trials
Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin.
Completed·—·Phase 4·NCT05529888·60 enrolled
Metastatic Prostate Cancer2 trials
Malignant Glioma2 trials
Fed2 trials
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
Completed·—·Phase 1·NCT01888328·26 enrolled
Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition
Completed·—·Phase 1·NCT01888224·61 enrolled
Clinical Trial2 trials
Glioblastoma Multiforme2 trials
Recurrence1 trial
Isotretinoin In Preventing Recurrences In Chronic Recurrent Dermatophytosis
Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2·NCT03471455·100 enrolled
Chemotherapy1 trial
Mild to Moderate Alzheimer's Disease1 trial
Pilot Study1 trial
Central Nervous System1 trial
Erythema1 trial
Lung Cancer1 trial
Recovery1 trial
Quality of Life1 trial
Impact of Isotretinoin in Different Doses on Quality of Life
Unknown status·—·Phase 4·NCT05316675·100 enrolled
Medulloblastoma1 trial
Lymphoma1 trial
Glioma1 trial
Recessive Dystrophic Epidermolysis Bullosa1 trial
Cervical Cancer1 trial
Adverse Effect1 trial
Relationship Between Serum Vitamin D Levels and Musculoskeletal Adverse Effects in Patients Using Isotretinoin
Completed·—·N/A·NCT04204304·177 enrolled
Remission1 trial
Acne Remission Maintenance by Weekend Systemic Isotretinoin
Completed·—·Phase 3·NCT06451237·60 enrolled
COVID-191 trial
T-cell Malignancies1 trial
Ichthyosis1 trial
HIV infection1 trial
Effectiveness1 trial
Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001073·150 enrolled
Patients With Solid Tumors1 trial
Head and Neck Cancer1 trial
Skin Cancer1 trial
Myelodysplastic Syndrome1 trial
Ganglioneuroblastoma, Nodular1 trial
Smell Dysfunction1 trial
Tinea1 trial
Dry Eye1 trial
High-Risk Neuroblastoma1 trial
Unspecified7 trials
Podocyte Retinoids
Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00098020·12 enrolled
Show 4 more trials
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition
Completed·—·Phase 1·NCT01888289·35 enrolled
Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition
Completed·—·Phase 1·NCT01888341·41 enrolled
Regulatory
FDA Approval Timeline[5]
May 7, 1982
ACCUTANE
NDA NDA018662
May 25, 2012
ABSORICA
NDA NDA021951
Nov 5, 2019
ABSORICA LD
NDA NDA211913
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Accutane drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Isotretinoin. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Retinoic Acid Receptor Agonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- CConrado Roberto Hoffmann Filho