Drug · Small Molecule

Tretinoin

CI-DRUG-00000612Explore in graph →NCIt C900 CHEMBL38 CIViC Approved

Regulatory

Approvals (14)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory12 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	ALTRENO ® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ALTRENO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)	approved	Aug 23, 2018	openfda
US FDA	—	Atralin Gel is indicated for topical treatment of acne vulgaris. Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 )	approved	Jul 26, 2007	openfda
US FDA	—	Efficacy supplement 2002-05-10 (see label)	approved	May 10, 2002	openfda
US FDA	Malignant Skin Neoplasm	Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 16 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	23	14	23	102	14	CA, US	Jan 26, 1973	1991-10
Leukemia	Phase4	Phase 4	7	3	20	52	0	—	—	1993-01
Malignant Hypopharyngeal Neoplasm	Phase3	Phase 3	1	1	1	1	0	—	—	Feb 20, 2025
Malignant Laryngeal Neoplasm	Phase3	Phase 3	1	1	1	1	0	—

Curated evidence

Clinical evidence (14)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–14 of 14 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
CEBPA Mutation1
Tretinoin	Acute Myeloid Leukemia

Clinical trials

Trials with this intervention (102)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 102 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05016349	Investigating the Potential Role of a Novel Quadrate Combination Therapy Mifepristone(Antiprogestrone), Tamoxifen, Retinoic Acid and Cannabidiol ( Selective Cyp 26 Inhibitor) for Treating Early Breast Cancer.	unknown	Phase 3	160	Mahmoud Ramadan mohamed ElkazzazOTHER	0	Aug 23, 2021	clinicaltrials
NCT04433169	All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Molecule

Record

Kind: Small Molecule
Mechanism: Retinoic acid receptor agonist
Targets: 3 genes
UNII: 5688UTC01R
Aliases: 2,4,6,8-Nonatetraenoic Acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-, Aberel, Acticin, Airol, Aknoten, (All-E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic Acid, All Trans-Retinoic Acid, All-trans Vitamin A Acid, Altreno, ATRA, Atralin, Avita, Beta-Retinoic Acid, Cordes Vas, Dermairol, Epi-Aberel, Eudyna, JAMP TRETINOIN, Kerlocal, NSC-122758, Oristar rna, Renova, Retin-a, Retin-A, Retin-a micro, Retin-A MICRO, Retinoic Acid, Retisol-A, Ro 5488, Stieva-A … (+19)

Data updated 19 hours agoSource updated unknown

Identifiers

Codes (5)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XF01	TRETINOIN
DIN (Health Canada)	02145839

FLT3 ITD2
Tretinoin	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Resistance	3	accepted	EID127 ATRA treatment did not effect overall survival in patients <60 years old with FLT3-ITD mutation. PMID 19965647 · Burnett et al., 2010 · Open in CIViC	civic
Anthracycline Antineoplastic Antibiotic + TretinoinCombination	Acute Promyelocytic Leukemia	Predictive	B	Supports Resistance	4	accepted	EID1112 In a study of 171 APL patients treated with combination ATRA/anthracycline chemotherapy, FLT3 ITD mutations (n=35) were associated with lower 3-year OS compared to the FLT3 ITD-negative group (62% vs.… (full text at CIViC) PMID 24981688 · Lucena-Araujo et al., 2014 · Open in CIViC	civic

NPM1 EXON 11 MUTATION3
NSC348884 + TretinoinCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID149 NSC348884 combined with ATRA treatment induces apoptosis in primary AML cells harboring mutant NPM1 but not in cells with wildtype NPM1 or both mutant NPM1 and FLT3-ITD. PMID 21719597 · Balusu et al., 2011 · Open in CIViC	civic
Tretinoin	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID137 ATRA treatment plus chemotherapy (daunorubicin, Ara-C, and thioguanine, N=113) did not effect overall survival in patients <60 years old with NPM1 mutation regardless of FLT3-ITD status compared to ch… (full text at CIViC) PMID 19965647 · Burnett et al., 2010 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	accepted	EID146 ATRA treatment improved overall and relapse-free survival in older (>60) patients with mutant NPM1 and without FLT3-ITD. PMID 19059939 · Schlenk et al., 2009 · Open in CIViC	civic

RARA Fusion3
Arsenic Trioxide + TretinoinCombination	Acute Promyelocytic Leukemia	Predictive	A	Supports Sensitivity Response	5	accepted	EID1091 ATRA/Arsenic combined with standard chemotherapy has been shown to induce a complete remission rate of greater than 75% of patients with acute promyelocytic leukemia harboring the PML-RARa fusion. PMID 11704842 · Degos et al., 2001 · Open in CIViC	civic
Tretinoin	Acute Promyelocytic Leukemia	Predictive	B	Supports Sensitivity Response	5	accepted	EID316 Fusion protein degradation is accelerated upon ATRA treatment of acute promyelocytic cells at pharmalogical concentrations. PMID 8674046 · Yoshida et al., 1996 · Open in CIViC	civic
〃	Acute Promyelocytic Leukemia	Predictive	C	Supports Sensitivity Response	3	accepted	EID1519 A 39-year old woman who presented with acute myeloid leukemia revealed a complicated genetic profile using conventional metaphase cytogenetics and FISH analysis. Whole genome sequencing elucidated a … (full text at CIViC) PMID 21505136 · Welch et al., 2011 · Open in CIViC	civic