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 28 indications[4].[1]

Accutane is one of 427 small molecule programs targeting Autosomal Recessive Congenital Ichthyosis. It is currently in Approved.

Indications

121

Total Trials

Active Trials

426

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Autosomal Recessive Congenital IchthyosisApproved

Toxic Epidermal NecrolysisActive, not recruiting

Central Nervous System NeoplasmApproved

Head and Neck Malignant NeoplasiaApproved

Skin CancerActive, not recruiting

AcneCompleted

FrecklesApproved

HIV-1 InfectionApproved

ErythemaActive, not recruiting

Alzheimer DiseaseApproved

Autosomal Recessive Congenital IchthyosisApproved

Approved

Toxic Epidermal NecrolysisPreclinical

Active, not recruiting

Central Nervous System NeoplasmApproved

Approved

Head and Neck Malignant NeoplasiaApproved

Approved

Skin CancerPreclinical

Active, not recruiting

AcneApproved

Completed

FrecklesApproved

Approved

HIV-1 InfectionApproved

Approved

ErythemaApproved

Active, not recruiting

Alzheimer DiseaseApproved

Approved

Showing 10 of 28 indications

Competition

Competitive Landscape

91 competitors in Alzheimer Disease

#DrugCompanyPhaseTrials

Accutane

CConrado Roberto Hoffmann Filho

Leqembi

1 3

Dayvigo

Eisai

Approved

1 4

Farxiga

Estrace

Avandia

Depakote

Soriatane

Lexapro

Calciferol

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Male Infertility

NCT07481370

Q1 2027

ApprovedNot yet recruiting

Tinea

NCT07675239

Phase 1Active, not recruiting

Recurrent Neuroblastoma

NCT01711554

Recruiting

Acne Vulgaris

NCT07834138

Q3 2027

Phase 2Active, not recruiting

Neuroblastoma

NCT04385277

Q4 2027

Post-ApprovalNot yet recruiting

OIC

NCT06698263

Clinical

Trials by Indication[1]

Neuroblastoma26 trials

High Dose Chemotherapy and Autologous Transplant for Neuroblastoma

Completed·MMasonic Cancer Center, University of Minnesota·N/A·NCT01526603·13 enrolled

Biological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00089258·74 enrolled

Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma

Unknown status·GGerman Society for Pediatric Oncology and Hematology GPOH gGmbH·Phase 3·NCT00410631·642 enrolled

Show 23 more trials

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

Unknown status·UUniversity of Leicester·Phase 3·NCT00030719·175 enrolled

Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00004110

Multiple Therapies in Treating Patients With Advanced Neuroblastoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00040872

Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT04385277·41 enrolled

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma

Completed·CChildren's Oncology Group·Phase 2·NCT00017368·42 enrolled

Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma

Completed·CChildren's Oncology Group·Phase 2·NCT01334515·52 enrolled

Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

Unknown status·GGerman Society for Pediatric Oncology and Hematology GPOH gGmbH·N/A·NCT00526318·360 enrolled

Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

Unknown status·CChildren's Cancer and Leukaemia Group·N/A·NCT00939965·75 enrolled

Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00005576·6 enrolled

ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma

Completed· United Therapeutics logo

United Therapeutics·Phase 1/2·NCT01592045·28 enrolled

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.

Withdrawn·YY-mAbs Therapeutics·Phase 2·NCT04909515

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

Completed·CChildren's Oncology Group·Phase 3·NCT00004188·495 enrolled

Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma

Completed·CChildren's Oncology Group·Phase 1·NCT00070200·31 enrolled

Vorinostat and Isotretinoin in Treating Patients With High-Risk Refractory or Recurrent Neuroblastoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01208454·29 enrolled

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03786783·42 enrolled

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma

Completed·CChildren's Oncology Group·Phase 3·NCT00567567·665 enrolled

Response-based Treatment of High-risk Neuroblastoma

Unknown status·SSamsung Medical Center·Phase 2·NCT02771743·54 enrolled

Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma

Completed·MMemorial Sloan Kettering Cancer Center·N/A·NCT02100930·69 enrolled

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

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00026312·1,449 enrolled

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma

Completed·CChildren's Oncology Group·Phase 3·NCT00499616·464 enrolled

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

Completed·CChildren's Oncology Group·Phase 1·NCT01175356·99 enrolled

Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients With High-Risk Neuroblastoma: A Phase II Study

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03033303·59 enrolled

Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01857934·153 enrolled

Acne Vulgaris10 trials

Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients

Completed·SSouth Valley University·N/A·NCT05869188·60 enrolled

Assessment of Serum Catestatin Level in Acne Vulgaris Patients

Recruiting·—·N/A·NCT07054398·60 enrolled

Effect of Oral Isotretinoin on The Level of SerumYKL40 in Acne Vulgaris Patients

Unknown status·AAlshimaa Abbas Mohamed Ebrahim·Phase 4·NCT05218486·60 enrolled

Show 7 more trials

The Effects of Systemic Isotretinoin Treatment on Adrenal Steroid and Sex Hormones Level in Severe Acne Vulgaris

Unknown status·MMarmara University··NCT05903716·40 enrolled

A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris

Completed·—·Phase 4·NCT04940767·31 enrolled

Serum TWEAK Levels in Acne Vulgaris

Completed·SSouth Valley University·Phase 2·NCT05684861·150 enrolled

Treatment of Acne Vulgaris Using NAFL in Combination With Isotretinoin and Pricking Blood Therapy

Completed·XxjpfW·N/A·NCT04156815·60 enrolled

Correlation Between Depression Scores and Serum NF-ĸB/NLRP3 Axis, Biotinidase, and HMGB After Treatment With Isotretinoin in Patients With Acne Vulgaris

Completed·MMostafa Bahaa·Phase 3·NCT06242288·40 enrolled

Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study

Recruiting·CCentre Hospitalier Universitaire de Nice·Phase 3·NCT06447480·420 enrolled

Clinical Characteristics and Longitudinal Changes in the Facial Skin Microbiome of Patients With Moderate-to-Severe Acne Vulgaris Treated With Isotretinoin: A Prospective Cohort Study

Recruiting·CCan Tho University of Medicine and Pharmacy··NCT07834138·90 enrolled

Acne4 trials

ABSORICA in Patients With Severe Recalcitrant Nodular Acne

Completed· Sun Pharmaceutical Industries Limited logo

Sun Pharmaceutical Industries Limited·Phase 4·NCT02457520·201 enrolled

Weekly Isotretinoin vs Tetracycline for Moderate Acne

Recruiting·MMedical University of South Carolina·Phase 1·NCT06225570·50 enrolled

The Lipid Profile of the Skin Surface in Acne

Completed·UUniversity of California, Davis··NCT02180425·30 enrolled

Show 1 more trial

De Novo Lipogenesis of Sebaceous Glands in Acne

Completed·UUniversity of California, Davis·Phase 1·NCT02620813·32 enrolled

Efficacy and Safety4 trials

Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne

Completed·CCipher Pharmaceuticals Inc.·Phase 3·NCT00975143·925 enrolled

Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts

Unknown status·CCentro Dermatológico Dr. Ladislao de la Pascua·Phase 3·NCT04290572·162 enrolled

Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea

Unknown status·FFederal University of São Paulo·Phase 4·NCT01139749·50 enrolled

Show 1 more trial

Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

Unknown status·FFederal University of São Paulo·Phase 2·NCT00842907·20 enrolled

Treatment3 trials

Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin

Completed·DDavid Smart·N/A·NCT03514771·15 enrolled

Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne

Completed·GGalderma R&D·Phase 3·NCT01474590·266 enrolled

Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabolites in the Treatment of Sever Acne

Completed·SShahid Beheshti University of Medical Sciences·Phase 1·NCT00416585·30 enrolled

59 more indications

Leukemia3 trials

Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00217412·60 enrolled

Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia

Withdrawn·RRush University Medical Center·Phase 2·NCT00003405

Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia

Completed·—·Phase 1·NCT01020539·18 enrolled

Kidney Cancer3 trials

Biological Therapy Plus Chemotherapy in Treating Patients With Metastatic or Recurrent Kidney Cancer

Completed·UUniversity of New Mexico·Phase 1/2·NCT00003585·35 enrolled

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

Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT00324740·14 enrolled

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

Oral2 trials

Investigation of the Effect of Oral Isotretinoin on Skin Thickness and Elasticity in Patients With Atrophic Acne Scar

Completed·IIstanbul Training and Research Hospital··NCT05413200·30 enrolled

Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin.

Completed·—·Phase 4·NCT05529888·60 enrolled

Glioblastoma Multiforme2 trials

Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT00555399·55 enrolled

Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00112502·178 enrolled

Metastatic Prostate Cancer2 trials

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

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00005847

Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Terminated·UUniversity of Medicine and Dentistry of New Jersey·Phase 2·NCT00176527·40 enrolled

Malignant Glioma2 trials

Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma

Terminated·WWake Forest University Health Sciences·Phase 1·NCT01103375·5 enrolled

Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas

Withdrawn·MM.D. Anderson Cancer Center·Phase 3·NCT00003564

Ichthyosis1 trial

A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis

Completed·TTimber Pharmaceuticals Inc.·Phase 2·NCT04154293·34 enrolled

Glioma1 trial

High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas

Completed·CChildren's Oncology Group·Phase 3·NCT00078988·1 enrolled

Proliferative Vitreoretinopathy1 trial

Isotretinoin for Proliferative Vitreoretinopathy

Completed·WWills Eye·Phase 4·NCT01445028·109 enrolled

Cervical Cancer1 trial

Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer

Terminated·UUniversity of Medicine and Dentistry of New Jersey·Phase 2·NCT00138151·33 enrolled

Central Nervous System1 trial

Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00867178·33 enrolled

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

Belinostat and Isotretinoin in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00334789·51 enrolled

Quality of Life1 trial

Impact of Isotretinoin in Different Doses on Quality of Life

Unknown status·—·Phase 4·NCT05316675·100 enrolled

Terminated·UUniversity Hospitals Cleveland Medical Center·Phase 1/2·NCT01560585·3 enrolled

HIV infection1 trial

Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000764·98 enrolled

Recessive Dystrophic Epidermolysis Bullosa1 trial

Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa

Completed·UUniversity of North Carolina·Phase 1·NCT00014729·20 enrolled

Adverse Effect1 trial

Relationship Between Serum Vitamin D Levels and Musculoskeletal Adverse Effects in Patients Using Isotretinoin

Completed·—·N/A·NCT04204304·177 enrolled

Pilot Study1 trial

Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study

Withdrawn·MMassachusetts General Hospital·N/A·NCT02795143

Skin Cancer1 trial

Isotretinoin in Preventing Skin Cancer

Completed·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·N/A·NCT00025012

Male Infertility1 trial

Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm

Not yet recruiting·UUniversity of Nebraska·Phase 2·NCT07481370·100 enrolled

Growth1 trial

Effects of Isotretinoin on the Growth Rate and Thickness of the Nail Plate

Completed·SSinan Özçelik··NCT04660916·70 enrolled

Head and Neck Cancer1 trial

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

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00054561

Randomized Controlled Trial1 trial

Oral Isotretinoin in Melasma a Randomized Controlled Trial

Unknown status·ZZagazig University·Phase 1·NCT06201624·40 enrolled

Myelodysplastic Syndrome1 trial

Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia

Completed·—·Phase 1/2·NCT00003619

OIC1 trial

13-cis Retinoic Acid (Isotretinoin) and Sperm Production

Not yet recruiting·UUniversity Hospital, Strasbourg, France·Phase 4·NCT06698263·100 enrolled

Multiple Myeloma1 trial

Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

Completed·FFox Chase Cancer Center·Phase 2·NCT00021359·17 enrolled

Erythema1 trial

Changes in PACAP, CGRP, and VIP Levels in Rosacea Patients on Systemic Isotretinoin and Their Association with Erythema

Completed·SSB Istanbul Education and Research Hospital·Phase 4·NCT06873087·30 enrolled

Recurrent Cancer1 trial

Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer

Completed·HHoag Memorial Hospital Presbyterian·Phase 2·NCT00002506

Juvenile Myelomonocytic Leukemia1 trial

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

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00025038·100 enrolled

COVID-191 trial

Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of COVID-19 ( Isotretinoin in Treatment of COVID-19) (Randomized)

Unknown status·KKafrelsheikh University·Phase 3·NCT04353180·100,000 enrolled

Onychomycosis1 trial

Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis

Not yet recruiting·ZZagazig University·Phase 1·NCT06485505·36 enrolled

T-cell Malignancies1 trial

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

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00038376·56 enrolled

Systemic1 trial

Effect of Systemic Retinoic Acid Use on Micro Ribonucleic Acid (mRNA) Expression

Not yet recruiting·MMedipol University·N/A·NCT07142070·25 enrolled

Cystic1 trial

Study of Two Dosages of Roaccutane in Cystic Acne

Completed·PPremier Specialists, Australia·Phase 4·NCT07228481·91 enrolled

Remission1 trial

Acne Remission Maintenance by Weekend Systemic Isotretinoin

Completed·—·Phase 3·NCT06451237·60 enrolled

Hirsutism1 trial

Effects of Isotretinoin on The Gonads and Hirsutism

Completed·KKayseri Education and Research Hospital·Phase 4·NCT02855138·80 enrolled

Actinic Keratosis1 trial

Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis

Completed·UUniversidade Federal de Goias·Phase 2·NCT02278861·60 enrolled

Clinical Trial1 trial

Clinical Trial of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·N/A·NCT06378983·100 enrolled

Medulloblastoma1 trial

Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT00392327·379 enrolled

Lymphoma1 trial

MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00098891·24 enrolled

Lung Cancer1 trial

Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer

Withdrawn·MM.D. Anderson Cancer Center·Phase 3·NCT00003599

Rosacea1 trial

Isotretinoin in Papular-Pustular Rosacea

Completed·LLaboratoires Bailleul-Biorga·Phase 3·NCT00882531·156 enrolled

Prolonged1 trial

Aflac ST1001 Prolonged Isotretinoin

Withdrawn·EEmory University·Phase 1·NCT01319838

Infusion1 trial

Long Term Continuous Infusion ch14.18/CHO Plus s.c. Aldesleukin (IL-2)

Unknown status·SSt. Anna Kinderkrebsforschung·Phase 1/2·NCT01701479·288 enrolled

Cognition1 trial

A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory

Completed·UUniversity of Aberdeen·Phase 4·NCT01404130·18 enrolled

CNS Embryonal Tumor1 trial

A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age

Recruiting·CC17 Council·Phase 1·NCT06942039·15 enrolled

Ganglioneuroblastoma, Nodular1 trial

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT06172296·478 enrolled

Dry Eye Disease (DED)1 trial

Assessment of the Effect of Oral Isotretinoin for Acne Treatment on the Ocular Surface and the Morphology of the Meibomian Gland

Completed·BBenha University·Preclinical·NCT07753811·60 enrolled

Recurrent Neuroblastoma1 trial

A Phase I Study of Lenalidomide and Anti-GD2 Mab Ch14.18 +/- Isotretinoin in Patients With Refractory/Recurrent Neuroblastoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT01711554·27 enrolled

Ganglioneuroblastoma1 trial

A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

Recruiting·CChildren's Oncology Group·Phase 3·NCT03126916·750 enrolled

Smell Dysfunction1 trial

Effects of Isotretinoin on Nasal Mucociliary Clearance and Olfactory Function

Completed·UUşak University·Preclinical·NCT07309341·54 enrolled

Tinea1 trial

Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety, and Cure Rate in Adult Patients With Tinea Corporis/Cruris: A Randomized Controlled Trial.

Not yet recruiting·PPak Emirates Military Hospital·Approved·NCT07675239·60 enrolled

Dry Eye1 trial

Effects of Systemic Isotretinoin Therapy on Choroidal Thickness and Retinal Vascular Parameters in Nodulocystic Acne Patients:A Prospevtive Study

Completed·DDemet Mutlu·Preclinical·NCT07675460·60 enrolled

High-Risk Neuroblastoma1 trial

A Comprehensive Safety Trial of Chimeric Antibody 14.18 (Ch14.18) With GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT01041638·105 enrolled

Unspecified7 trials

Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects

Completed·PPierre Fabre Dermatology·Phase 1·NCT01861626·45 enrolled

Effects of Isotretinoin on CYP2D6 Activity

Completed·UUniversity of Washington·Phase 4·NCT03076021·33 enrolled

Weekly Isotretinoin Therapy Study

Completed·MMedical University of South Carolina·Phase 1/2·NCT04594759·22 enrolled

Show 4 more trials

Bioequivalence Study for an Isotretinoin

Completed· GSK logo

GSK·Phase 1·NCT01863615·36 enrolled

Podocyte Retinoids

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00098020·12 enrolled

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

Mar 25, 2013

ZENATANE

NDA ANDA202099

Feb 23, 2015

ZENATANE

NDA ANDA202099

Sep 3, 2015

ZENATANE

NDA ANDA202099

Feb 4, 2016

ZENATANE

NDA ANDA202099

Jul 8, 2016

ZENATANE

NDA ANDA202099

Jun 17, 2017

ZENATANE

NDA ANDA202099

Apr 23, 2018

ZENATANE

NDA ANDA202099

May 2, 2018

ZENATANE

NDA ANDA202099

Aug 31, 2018

ZENATANE

NDA ANDA202099

Nov 5, 2019

ABSORICA LD

NDA NDA211913

Nov 16, 2020

ZENATANE

NDA ANDA202099

Dec 9, 2020

ZENATANE

NDA ANDA202099

Oct 8, 2021

ZENATANE

NDA ANDA202099

Nov 9, 2021

ZENATANE

NDA ANDA202099

Aug 4, 2022

ZENATANE

NDA ANDA202099

Aug 23, 2022

ZENATANE

NDA ANDA202099

Oct 6, 2022

ZENATANE

NDA ANDA202099

Mar 24, 2023

ZENATANE

NDA ANDA202099

Feb 9, 2026

ZENATANE

NDA ANDA202099

Aug 21, 2026

ZENATANE

NDA ANDA202099

Oct 7, 2026

ZENATANE

NDA ANDA202099

Sources

References

[1]
ClinicalTrials.gov — 121 trial records for Isotretinoin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Accutane drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Isotretinoin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Isotretinoin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA ANDA202099). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Accutane. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

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

Patent Landscape[6]

Patent Cliff

May 29, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9750711May 29, 2035

9700535Aug 4, 2035

Accutane

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Neuroblastoma26 trials

Acne Vulgaris10 trials

Acne4 trials

Efficacy and Safety4 trials

Treatment3 trials

Leukemia3 trials

Kidney Cancer3 trials

Fed2 trials

Oral2 trials

Glioblastoma Multiforme2 trials

Metastatic Prostate Cancer2 trials

Malignant Glioma2 trials

Ichthyosis1 trial

Glioma1 trial

Proliferative Vitreoretinopathy1 trial

Cervical Cancer1 trial

Central Nervous System1 trial

Effectiveness1 trial

Patients With Solid Tumors1 trial

Quality of Life1 trial

Recovery1 trial

Recurrence1 trial

Mild to Moderate Alzheimer's Disease1 trial

HIV infection1 trial

Recessive Dystrophic Epidermolysis Bullosa1 trial

Adverse Effect1 trial

Pilot Study1 trial

Skin Cancer1 trial

Male Infertility1 trial

Growth1 trial

Head and Neck Cancer1 trial

Randomized Controlled Trial1 trial

Myelodysplastic Syndrome1 trial

OIC1 trial

Multiple Myeloma1 trial

Erythema1 trial

Recurrent Cancer1 trial

Juvenile Myelomonocytic Leukemia1 trial

COVID-191 trial

Onychomycosis1 trial

T-cell Malignancies1 trial

Systemic1 trial

Cystic1 trial

Remission1 trial

Hirsutism1 trial

Actinic Keratosis1 trial

Clinical Trial1 trial

Medulloblastoma1 trial

Lymphoma1 trial

Lung Cancer1 trial

Rosacea1 trial

Prolonged1 trial

Infusion1 trial

Cognition1 trial

CNS Embryonal Tumor1 trial

Ganglioneuroblastoma, Nodular1 trial

Dry Eye Disease (DED)1 trial

Recurrent Neuroblastoma1 trial

Ganglioneuroblastoma1 trial

Smell Dysfunction1 trial

Tinea1 trial

Dry Eye1 trial

High-Risk Neuroblastoma1 trial

Unspecified7 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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