Retin-A

(Tretinoin)

ApprovedSmall molecule

Tretinoin is used to treat acne by helping skin cells turn over faster and unclog pores. It's also used to reduce wrinkles and improve sun-damaged skin texture.[2] Retin-A is currently approved and in use across 24 indications[4].[1]

Retin-A is one of 512 small molecule programs targeting Acute Promyelocytic Leukemia. It is currently in Approved.

Indications

Total Trials

Active Trials

511

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Acute Promyelocytic LeukemiaCompleted

Skin AgingActive, not recruiting

Hyperpigmentation of the SkinActive, not recruiting

VitiligoActive, not recruiting

FrecklesActive, not recruiting

AutismApproved

Basal Cell CarcinomaApproved

Squamous Cell CarcinomaApproved

Breast NeoplasmApproved

AnemiaApproved

Acute Promyelocytic LeukemiaPhase 3

Completed

Skin AgingPreclinical

Active, not recruiting

Hyperpigmentation of the SkinApproved

Active, not recruiting

VitiligoPreclinical

Active, not recruiting

FrecklesApproved

Active, not recruiting

AutismApproved

Approved

Basal Cell CarcinomaApproved

Approved

Squamous Cell CarcinomaApproved

Approved

Breast NeoplasmApproved

Approved

AnemiaApproved

Approved

Showing 10 of 24 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Retin-A

VValeant Pharmaceuticals

Approved

49 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—8

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—9

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

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

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Acute Promyelocytic Leukemia

NCT01409161

Q2 2029

Phase 3Active, not recruiting

Acute Promyelocytic Leukemia

NCT02339740

Q3 2029

Phase 2Recruiting

Toxicity

NCT06358677

Clinical

Trials by Indication[1]

Acute Promyelocytic Leukemia11 trials

S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

Completed·SSWOG Cancer Research Network·Phase 2·NCT00551460·78 enrolled

S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia

Completed·SSWOG Cancer Research Network·Phase 3·NCT00492856·105 enrolled

Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002701·750 enrolled

Show 8 more trials

Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00016159·35 enrolled

Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00276601

Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT02339740·158 enrolled

Tretinoin, Cytarabine, and Daunorubicin Hydrochloride With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00003934·420 enrolled

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

Completed·CChildren's Oncology Group·Phase 3·NCT00866918·106 enrolled

Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia

Completed·TTechnische Universität Dresden·Phase 3·NCT02688140·135 enrolled

Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01409161·151 enrolled

Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00528450·1 enrolled

Irritation3 trials

A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products

Completed·BBausch Health Americas, Inc.·Phase 4·NCT01313728·26 enrolled

Evaluation of Irritation That Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face.

Completed·BBausch Health Americas, Inc.·Phase 4·NCT00714714·25 enrolled

Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face

Completed·BBausch Health Americas, Inc.·Phase 4·NCT00919191·26 enrolled

Hematologic Cancer2 trials

Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00006239

Arsenic Trioxide With or Without Tretinoin in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy

Terminated·WWashington University School of Medicine·Phase 1/2·NCT00006220·5 enrolled

Acne Vulgaris2 trials

Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

Completed· AbbVie logo

AbbVie·Phase 4·NCT00835198·163 enrolled

Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

Completed·—·Phase 2·NCT04080869·20 enrolled

Acute Myeloid Leukemia2 trials

Combination Chemotherapy With or Without Filgrastim and/or Tretinoin in Treating Patients With Acute Myeloid Leukemia

Completed·MMedical Research Council·Phase 3·NCT00005863

Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·PPaolo Caimi, MD·Phase 1·NCT01820624·12 enrolled

25 more indications

Non-Small Cell Lung Cancer2 trials

Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Unknown status·—·Phase 2·NCT00514293·39 enrolled

Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Unknown status·—·Phase 2·NCT00005825

Treatment2 trials

Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles

Completed·JJohns Hopkins University·Phase 2·NCT01283464·24 enrolled

A Study of Different Use Regimens Using Two Acne Treatments

Completed·BBausch Health Americas, Inc.·Phase 4·NCT00907257·247 enrolled

Neuroblastoma1 trial

Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma

Completed·GGerman Society for Pediatric Oncology and Hematology GPOH gGmbH·Phase 2·NCT00017225

Bone Marrow Transplantation1 trial

Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia

Unknown status·MMedical Research Council·Phase 3·NCT00002658·2,000 enrolled

Adenoid Cystic Carcinoma1 trial

A Trial of All-trans Retinoic Acid (ATRA) in Advanced Adenoid Cystic Carcinoma

Completed·—·Phase 2·NCT03999684·18 enrolled

Prevention1 trial

Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

Withdrawn·JJohns Hopkins University·N/A·NCT01349556

Mycosis Fungoides1 trial

Tretinoin in Treating Patients With Mycosis Fungoides or Sezary Syndrome

Completed·NNorthwestern University·Phase 2·NCT00002479

Efficacy and Safety1 trial

Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

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

Photoaging1 trial

A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging

Completed·GGalderma Brasil Ltda.·Phase 3·NCT01406080·128 enrolled

Myeloid Malignancies1 trial

A Study of Bomedemstat (IMG-7289/MK-3543) With and Without ATRA, in Participants With Advanced Myeloid Malignancies (IMG-7289-CTP-101/MK-3543-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT02842827·45 enrolled

Relapsed or Refractory1 trial

Phase I/II Trial of ATRA and TCP in Patients With Relapsed or Refractory AML and no Intensive Treatment is Possible

Unknown status·MMartin-Luther-Universität Halle-Wittenberg·Phase 1/2·NCT02261779·16 enrolled

Myelodysplastic Syndromes1 trial

Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT00382200·54 enrolled

Cancer1 trial

UMCC 9609 Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia

Completed·UUniversity of Michigan Rogel Cancer Center·N/A·NCT00003598·180 enrolled

Trial1 trial

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Steroid1 trial

Addition of a Topical Steroid to a Topical Retinoid in Acne Patients

Unknown status·CCarilion Clinic·N/A·NCT02704507·20 enrolled

Quality of Life1 trial

Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction

Unknown status·IIndonesia University·N/A·NCT06181838·40 enrolled

Myelodysplastic Syndrome1 trial

Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·LLeukemia Research Fund·Phase 3·NCT00005823·2,000 enrolled

Adult1 trial

Study of TCP-ATRA for Adult Patients With AML and MDS

Completed·UUniversity of Miami·Phase 1·NCT02273102·17 enrolled

Acne1 trial

De Novo Lipogenesis of Sebaceous Glands in Acne

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

Effectiveness1 trial

A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel

Completed· GSK logo

GSK·Phase 3·NCT00689117·1,649 enrolled

Toxicity1 trial

Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors

Recruiting·UUniversity of Utah·Phase 2·NCT06358677·25 enrolled

Aging1 trial

Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging

Completed·CCosmetique Active International·N/A·NCT00974480·120 enrolled

Striae distensae1 trial

Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

Completed·MMerete Haedersdal·Phase 2·NCT05461755·20 enrolled

Metastatic Lung Non-Small Cell Carcinoma1 trial

A Phase Ib Dose De-Escalation Study of All-Trans Retinoic Acid (ATRA) and Atezolizumab in Patients With Advanced Non-Small Cell Lung Cancer

Completed·DDwight Owen·Phase 1·NCT04919369·18 enrolled

Unspecified3 trials

Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo

Completed·SSpear Pharmaceuticals·Phase 3·NCT01243450·958 enrolled

Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel

Completed·SSpear Pharmaceuticals·Phase 3·NCT02249767·574 enrolled

Tretinoin With or Without Fenretinide in Treating Patients With Dysplastic Nevus Syndrome

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00003601·38 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

RETIN-A

NDA NDA017340

Jan 1, 1982

RETIN-A

NDA NDA017955

Jan 1, 1982

RETIN-A

NDA NDA017579

Jan 1, 1982

RETIN-A

NDA NDA017522

Jan 1, 1982

RETIN-A

NDA NDA016921

Sep 16, 1988

RETIN-A

NDA NDA019049

Nov 22, 1995

VESANOID

NDA NDA020438

Dec 29, 1995

RENOVA

NDA NDA019963

Jan 14, 1997

AVITA

NDA NDA020404

Jan 29, 1998

AVITA

NDA NDA020400

Aug 31, 2000

RENOVA

NDA NDA021108

May 10, 2002

RETIN-A MICRO

NDA NDA020475

Jul 26, 2007

ATRALIN

NDA NDA022070

Aug 23, 2018

ALTRENO

NDA NDA209353

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for Tretinoin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Retin-A drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tretinoin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tretinoin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209353). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Retin-A. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Valeant Pharmaceuticals 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: VValeant Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Aug 22, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10653656Aug 22, 2038

11324710Aug 22, 2038

Retin-A

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2029

Q3 2029

Trials by Indication[1]

Acute Promyelocytic Leukemia11 trials

Irritation3 trials

Hematologic Cancer2 trials

Acne Vulgaris2 trials

Acute Myeloid Leukemia2 trials

Non-Small Cell Lung Cancer2 trials

Treatment2 trials

Neuroblastoma1 trial

Bone Marrow Transplantation1 trial

Adenoid Cystic Carcinoma1 trial

Prevention1 trial

Mycosis Fungoides1 trial

Efficacy and Safety1 trial

Photoaging1 trial

Myeloid Malignancies1 trial

Relapsed or Refractory1 trial

Myelodysplastic Syndromes1 trial

Cancer1 trial

Trial1 trial

Steroid1 trial

Quality of Life1 trial

Myelodysplastic Syndrome1 trial

Adult1 trial

Acne1 trial

Effectiveness1 trial

Toxicity1 trial

Aging1 trial

Striae distensae1 trial

Metastatic Lung Non-Small Cell Carcinoma1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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