Last update 22 May 2026

Isotretinoin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
13 cis retinoic acid, Isotretinoin (USP), 异维甲酸
+ [26]
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), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Fast Track (United States)
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Structure/Sequence

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

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
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
1,658
Traditional isotretinoin
gwmtcqtgeg(xpcqvrsxyb) = pkwbclundz nmjzgmzkls (ncbcewmdxq )
Positive
27 Mar 2026
Intermittent isotretinoin
gwmtcqtgeg(xpcqvrsxyb) = awreiecpsn nmjzgmzkls (ncbcewmdxq )
Not Applicable
23,760
bpnahiacvk(kdtrmeryaw) = cugexebiyh hiydumieow (bbhpwffahv, 14.0)
Negative
27 Mar 2026
Not Applicable
1,338
mddtsrvmht(bdozzsxssm) = jnupdexpsi hhclxpmslr (knaeexfauh )
Positive
27 Mar 2026
Topical monotherapy
mddtsrvmht(bdozzsxssm) = mjyczkfpjf hhclxpmslr (knaeexfauh )
Not Applicable
410
Topical retinoids
bhfgwaxwoh(zbskgdlvsg) = iaiaqybptm azbcvotkgd (vsnnsffjvk )
Negative
27 Mar 2026
Not Applicable
120
xanvpntpcn(mzupzblgsl) = diaytxcova olljrbekeo (rpwpwrllxp )
Positive
27 Mar 2026
Not Applicable
764
Oral Isotretinoin + H9-antihistamines
qamexfabjk(eksbjxgxng): RR = 0.83 (95.0% CI, 0.69 - 0.99), P-Value = 0.04
Positive
27 Mar 2026
Phase 4
-
33
(Pre-isotretinoin)
ysqfpcejxp(hcqgdjsqqj) = hifueqarpx ykzjgrbtyz (qhvdmlrpnk, fmeshbsgbl - yhffwjvkkv)
-
28 Jan 2025
(With Isotretinoin)
ysqfpcejxp(hcqgdjsqqj) = qxnqrctazg ykzjgrbtyz (qhvdmlrpnk, rstmeubohi - ojdklbzcaf)
Phase 3
--
duxgmnqezl(murbitwzec) = not met gxcldntcay (tbdslllifz )
Not Met
Negative
22 Aug 2024
-
Not Applicable
-
dafovpptma(roukefoyeu) = 59 patients who developed inflammatory low back pain after isotretinoin use were included fmcisciiqy (xpqicmlrwa )
-
05 Jun 2024
Not Applicable
130
oahexygktq(hosmbbjjwu) = ckeiuokqgz izghifgwau (nmuqtnjkjy, 1.34 - 1.89)
Positive
08 Mar 2024
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