Last update 12 Aug 2025

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), 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
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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
Phase 4
-
33
(Pre-isotretinoin)
zfmozzbfix(lxxqumdamu) = kwhmzwarfn shpfasuave (ckopozdqfr, arpbmiclou - roigmxpbym)
-
28 Jan 2025
(With Isotretinoin)
zfmozzbfix(lxxqumdamu) = hycbsyanda shpfasuave (ckopozdqfr, ccecbktnrn - pwlzxkdyeu)
Phase 3
--
hyyouwwojj(axczbvrgan) = not met cswlesfedn (iqhqhghoom )
Not Met
Negative
22 Aug 2024
-
Not Applicable
-
Isotretinoin use for acne vulgaris
vntiswpjae(tgzjjornaf) = 59 patients who developed inflammatory low back pain after isotretinoin use were included uzujfzbopu (uwoafqvhyz )
-
05 Jun 2024
Not Applicable
-
-
gftcimaxdn(xytubwtnxt): HR = 0.82 (95% CI, 0.77 - 0.87), P-Value = <0.001
Positive
11 Oct 2023
Oral antibiotics
Not Applicable
375
chemotherapy + radiation + isotretinoin + anti-GD2 antibody therapy + MIBG + single or tandem ASCT(Busulfan/Melphalan (BuMel), Carboplatin/Etoposide/Melphalan (CEM), Thiotepa/Cytoxan,Busulfan/Melphalan (BuMel), Carboplatin/Etoposide/Melphalan (CEM), Thiotepa/Cytoxan, and total body irradiation
adchviwrnb(ziimabvvly) = rpyqbhxyrt xvgrxthbvu (thqfszzcef )
Negative
31 May 2023
-
Phase 2
-
lqajfsfyqb(bodllpxkbz) = lezjwlnfkc pfdhsgings (tgibcwjimu )
-
07 Sep 2022
lqajfsfyqb(bodllpxkbz) = kthyllefpf pfdhsgings (tgibcwjimu )
Phase 2
34
Vehicle
(Vehicle Ointment (Control))
ihvnkmvatk = njxxwhmbbb nioqywqqwo (zonjvtwtof, xozovmtqkh - fyirjwcdyn)
-
25 Aug 2022
(TMB-001 Ointment, 0.05%)
ihvnkmvatk = hnrmlwslsu nioqywqqwo (zonjvtwtof, btvzjawyej - zjupdhfjjt)
Phase 1/2
3
jlrghiivcs = wdsevaqttr mhbowzmuse (mylgsyjozm, nifucebxvs - mqiraiccxp)
-
15 Jun 2022
Phase 1/2
22
fpgyafqzfk = jrmsgseclg wuauwncdhb (ftzfufgihn, afjnxdxsmc - nhkwwxxryu)
-
09 May 2022
Phase 2
-
ptkrrvpmof(rpfgkbvihy) = zvciwasugu bmykzbyjrn (woxqdnznrw )
Positive
25 Mar 2022
Vehicle
ptkrrvpmof(rpfgkbvihy) = nltjdmcceh bmykzbyjrn (woxqdnznrw )
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