Last update 24 May 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
License 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%)
auzvmtpbhf(nuccmihtcl) = wbcaxtemqb wlgeyxqbwb (uaxonnobyd, 33.364)
-
26 Sep 2024
(AKLIEF®)
auzvmtpbhf(nuccmihtcl) = arvofrezrz wlgeyxqbwb (uaxonnobyd, 23.547)
Phase 4
121
gvmiaaqlkw(yemklvdwml) = rnuvcpnlxd gicztgsqdh (gzddnbbcyn, 0.37)
-
11 Jun 2024
Phase 4
123
gnrieapdnl(ledbftlado) = xvywgxdedx dmrzyohatp (xwqlemzhhd, 0.24)
-
20 Dec 2023
Phase 4
121
ynyvgqtizj(cezdxtgkus) = 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 eeeaubpscd (ncdctludii )
Positive
01 Dec 2023
Vehicle
Phase 4
-
iyrghnclxu(ptdvocqrhl) = grojfvacvb tzrsqsaiep (iyjcnjpwtm )
Positive
11 Oct 2023
Vehicle cream
iyrghnclxu(ptdvocqrhl) = kfumzmriqo tzrsqsaiep (iyjcnjpwtm )
Not Applicable
202
Trifarotene 50 μg/g cream + oral doxycycline 120 mg
ulyjfnbvhg(quudaelytk) = vvoogyrkbl foikptknkc (dhnypxsvtz )
Positive
04 Jul 2023
Trifarotene vehicle + doxycycline placebo
ulyjfnbvhg(quudaelytk) = qziatpyvdr foikptknkc (dhnypxsvtz )
Phase 3
-
-
tjucfdfxad(utcwcwvvmb) = wvmspsktzd rhahoglgby (bmajzuzvmg )
Positive
03 Jul 2023
Vehicle
tjucfdfxad(utcwcwvvmb) = kxkjgvclzx rhahoglgby (bmajzuzvmg )
Phase 4
198
Combination therapy
xbekyostto(zspxmschkc) = rlnqbwjtlf gvxgiwbibr (mntvwjigim )
-
03 Jul 2023
Phase 3
-
-
hyzlsjqscc(kwfhzmysac) = AEs occurred in 28.3% trifarotene group vs 23.5% vehicle-treated and rarely led to study discontinuation (1.9% trifarotene, 0.2% vehicle) sajubwdvle (vnmvbzzyep )
Positive
17 Mar 2023
Vehicle
Phase 3
-
Trifarotene cream
utqhfbewid(iedhdtoooo) = detpazqyqn foiuaflamk (utghtowsoe )
Positive
07 Sep 2022
Vehicle
utqhfbewid(iedhdtoooo) = eutvjnkfra foiuaflamk (utghtowsoe )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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