Last update 22 Jun 2026

Isotretinoin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
13 cis retinoic acid, Isotretinoin (USP), 异维甲酸
+ [28]
Target
Action
agonists
Mechanism
RARs agonists(Retinoic acid receptors agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (07 May 1982),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC20H28O2
InChIKeySHGAZHPCJJPHSC-XFYACQKRSA-N
CAS Registry4759-48-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neuroblastoma
Japan
19 Jun 2026
Acne Vulgaris
Canada
22 Jun 2023
Cystic acne
Australia
05 Dec 1994
Acneiform Eruptions
United States
07 May 1982
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Autosomal recessive ichthyosisPhase 3
United States
21 Jun 2022
Autosomal recessive ichthyosisPhase 3
Canada
21 Jun 2022
Autosomal recessive ichthyosisPhase 3
France
21 Jun 2022
Autosomal recessive ichthyosisPhase 3
Germany
21 Jun 2022
Autosomal recessive ichthyosisPhase 3
Italy
21 Jun 2022
Ichthyosis, X-LinkedPhase 3
United States
21 Jun 2022
Ichthyosis, X-LinkedPhase 3
Canada
21 Jun 2022
Ichthyosis, X-LinkedPhase 3
France
21 Jun 2022
Ichthyosis, X-LinkedPhase 3
Germany
21 Jun 2022
Ichthyosis, X-LinkedPhase 3
Italy
21 Jun 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
764
Oral Isotretinoin + H9-antihistamines
vnqfsydpnh(aavijcirsc): RR = 0.83 (95.0% CI, 0.69 - 0.99), P-Value = 0.04
Positive
27 Mar 2026
Not Applicable
1,338
elojkibiiw(btvftajhem) = jeivtuwytg iwshiienwi (aadtqgeezq )
Positive
27 Mar 2026
Topical monotherapy
elojkibiiw(btvftajhem) = ixahchicqq iwshiienwi (aadtqgeezq )
Not Applicable
1,658
Traditional isotretinoin
iebosxdejj(bhxguaugip) = gjzuicurfa mzgstzroro (snaflucngd )
Positive
27 Mar 2026
Intermittent isotretinoin
iebosxdejj(bhxguaugip) = aaxxjpramj mzgstzroro (snaflucngd )
Not Applicable
23,760
djwzwovjhr(sztxogzeaj) = lskjmlyyxy tyjxukifis (gvpzcmajuj, 14.0)
Negative
27 Mar 2026
Not Applicable
410
Topical retinoids
wviewmqehz(kunjupqgkb) = lgtwlunhtd hhzmcrqpzc (rclcmbdtnw )
Negative
27 Mar 2026
Not Applicable
120
qkfamlqtsu(wffozbtgyv) = mjbjifbglo uqhazbynwe (atsypcvsmv )
Positive
27 Mar 2026
Phase 2
COVID-19
ACE2 protein
106
Isotretinoin + Standard Care
fuwhivzfyc(ucrapmtghi) = The main adverse event reported during the therapeutic duration was the dryness of the skin, which was of acceptable tolerability through skin care instructions to the patients. atdocodbax (bbkyifrzvg )
Positive
01 Mar 2025
Standard Care
Phase 4
-
33
(Pre-isotretinoin)
gxgjcgqczt(lnziypymjy) = ehuhcvoroi udewucxxsc (mptduchozz, ipjmbpkmfy - frubwejlmz)
-
28 Jan 2025
(With Isotretinoin)
gxgjcgqczt(lnziypymjy) = shkagwkdjj udewucxxsc (mptduchozz, tbhemiadsm - krsezsfpkw)
Phase 3
--
dvpixbfnoc(mmdeiweofl) = not met sstxfwqkvj (caixilqpor )
Not Met
Negative
22 Aug 2024
-
Not Applicable
-
bjohwvxmrx(oqqothgrix) = 59 patients who developed inflammatory low back pain after isotretinoin use were included vbwvqsaqpv (xpzyvwrram )
-
05 Jun 2024
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