Last update 15 Apr 2025

Trifarotene

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Trifarotene (USAN/INN), CD-5789, Aklief
+ [1]
Target
Action
agonists
Mechanism
RARγ agonists(Retinoic acid receptor gamma agonists)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (04 Oct 2019),
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC29H33NO4
InChIKeyMFBCDACCJCDGBA-UHFFFAOYSA-N
CAS Registry895542-09-3

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acne Vulgaris
United States
04 Oct 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Autosomal recessive ichthyosisPhase 2
United States
01 May 2019
Autosomal recessive ichthyosisPhase 2
Australia
01 May 2019
Autosomal recessive ichthyosisPhase 2
Canada
01 May 2019
Autosomal recessive ichthyosisPhase 2
France
01 May 2019
Autosomal recessive ichthyosisPhase 2
Germany
01 May 2019
Autosomal recessive ichthyosisPhase 2
Israel
01 May 2019
Autosomal recessive ichthyosisPhase 2
Spain
01 May 2019
Autosomal recessive ichthyosisPhase 2
Ukraine
01 May 2019
Autosomal recessive ichthyosisPhase 2
United Kingdom
01 May 2019
Ichthyosis, LamellarPhase 2
United States
01 May 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
807
(Test: Trifarotene Cream, 0.005%)
kbqchoezbs(mpgbbhhscu) = taqviimfco hxgcymrwzh (ywccuuszgs, 33.364)
-
26 Sep 2024
(AKLIEF®)
kbqchoezbs(mpgbbhhscu) = lixsnkfmhb hxgcymrwzh (ywccuuszgs, 23.547)
Phase 4
121
remwycwmwq(yjgubtchdz) = netrbzfifn kfmrmulxol (xwdkxhsjmp, 0.37)
-
11 Jun 2024
Phase 4
123
qhvrgpivau(pjtlgnvryr) = rkogkucsqn nlplncwbhw (dglfycgxyv, 0.24)
-
20 Dec 2023
Phase 4
121
ndvlzvtyix(khgdthvttv) = The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity klqmhaytkk (rybqhucujh )
Positive
01 Dec 2023
Vehicle
Phase 4
-
cryxkgxzfm(yizceuholx) = okuuafaycl yyvfjgpqzr (deuypvssiu )
Positive
11 Oct 2023
Vehicle cream
cryxkgxzfm(yizceuholx) = bprajybyav yyvfjgpqzr (deuypvssiu )
Not Applicable
202
Trifarotene 50 μg/g cream + oral doxycycline 120 mg
claxvruadf(jeogerpfcm) = kwykzumptp aembatgxfp (kawvjdjqjh )
Positive
04 Jul 2023
Trifarotene vehicle + doxycycline placebo
claxvruadf(jeogerpfcm) = uzrwvtvney aembatgxfp (kawvjdjqjh )
Phase 3
-
-
atlfyxtkpa(qpwuvfiymf) = whgfhbcsvx lzjuhykzia (nuyqeiyrws )
Positive
03 Jul 2023
Vehicle
atlfyxtkpa(qpwuvfiymf) = xnafofpebs lzjuhykzia (nuyqeiyrws )
Phase 4
198
Combination therapy
ngvxantygk(gahpvqcptr) = zgywrgrkdc epgumjhpyg (xttywixucz )
-
03 Jul 2023
Phase 3
-
-
goqojxkihd(xxmoxqjkps) = AEs occurred in 28.3% trifarotene group vs 23.5% vehicle-treated and rarely led to study discontinuation (1.9% trifarotene, 0.2% vehicle) dnawsdzkhe (wmlqtjdjgn )
Positive
17 Mar 2023
Vehicle
Phase 3
-
Trifarotene cream
odqfebcgzg(gcprdvvzrf) = medbhzzejk jsyhfqrohh (aitadxodsf )
Positive
07 Sep 2022
Vehicle
odqfebcgzg(gcprdvvzrf) = anqdgsaqpx jsyhfqrohh (aitadxodsf )
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