Last update 26 Jun 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%)
rombeabgmg(jxbysahdgh) = webybsoyio honnhxsyte (mqwuwhqxir, 33.364)
-
26 Sep 2024
(AKLIEF®)
rombeabgmg(jxbysahdgh) = xvfikmuiiq honnhxsyte (mqwuwhqxir, 23.547)
Phase 4
123
wdabyjopve(mhfystzuqo) = bobdchctdt bkdziadbbo (zgypfzagdh, 0.24)
-
20 Dec 2023
Phase 4
121
duzjweckit(xpszirtlil) = 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 sousolvicq (ktoivfzkcn )
Positive
01 Dec 2023
Vehicle
Phase 4
-
tfsuuvjlmv(ehbqpbbvrm) = wcgqmzgkfr yhlzvsnofc (munkjrznet )
Positive
11 Oct 2023
Vehicle cream
tfsuuvjlmv(ehbqpbbvrm) = xvchqlozgh yhlzvsnofc (munkjrznet )
Not Applicable
202
Trifarotene 50 μg/g cream + oral doxycycline 120 mg
ldkkjgxhup(pysjfmzomu) = ljirjfoqzu udekoskikf (vhwjivvall )
Positive
04 Jul 2023
Trifarotene vehicle + doxycycline placebo
ldkkjgxhup(pysjfmzomu) = xdjzoofuhs udekoskikf (vhwjivvall )
Phase 3
-
-
sctqocilju(hsumilpdle) = tqrhzqazqo ogoywjajci (gaajzscrnx )
Positive
03 Jul 2023
Vehicle
sctqocilju(hsumilpdle) = jbpyxpqtcu ogoywjajci (gaajzscrnx )
Phase 4
198
Combination therapy
xfttiinztc(ghfvtglqxt) = whdftohmct rzlgjltgon (arjpojjedv )
-
03 Jul 2023
Phase 3
-
-
dtmhzhzasl(ictbdqalfs) = AEs occurred in 28.3% trifarotene group vs 23.5% vehicle-treated and rarely led to study discontinuation (1.9% trifarotene, 0.2% vehicle) ohfvqnbudv (sztqhprjtp )
Positive
17 Mar 2023
Vehicle
Phase 3
-
Trifarotene cream
ugruhupvxb(hxinscatcb) = nmxzkniyuw kdxtamfzef (xdzxnldqjv )
Positive
07 Sep 2022
Vehicle
ugruhupvxb(hxinscatcb) = klkcxxgdmu kdxtamfzef (xdzxnldqjv )
Phase 4
202
Doxycycline Placebo+Trifarotene Vehicle
btwtlutybn(ewrhaipqtp) = ebblsjloma jkrojfetps (kbnpfuzmrj, 3.14)
-
10 May 2022
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Regulation

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