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References
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[1]
[PDF] AKLIEF Cream - accessdata.fda.govIn animal studies, trifarotene was present in rat milk with oral administration of the drug. When a drug is present in animal milk, it is likely that the ...
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[2]
Trifarotene: A Novel Therapeutic Option for Acne - PMC - NIHMay 27, 2022 · Trifarotene is basically a novel fourth-generation locally applied retinoid approved for the first time in the regimens of both face and truncal acnes.
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[3]
Trifarotene | C29H33NO4 | CID 11518241 - PubChem - NIHTrifarotene is a topical retinoid cream used in the treatment of acne vulgaris that was first approved for use in the United States in October 2019.
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[4]
Assessing the Safety and Efficacy of Trifarotene in the ... - NIHJul 26, 2021 · Trifarotene is a new first-in-class fourth-generation topical retinoid that has been uniquely studied in the treatment of both facial and truncal acne.
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[5]
Trifarotene Reduces Risk for Atrophic Acne Scars - PubMed CentralOct 15, 2023 · Trifarotene is the most recent topical retinoid to receive regulatory approval for treatment of acne; it has a very low systemic absorption, ...<|control11|><|separator|>
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[6]
Trifarotene Topical: MedlinePlus Drug Information### Summary of Trifarotene Topical
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[7]
Galderma Receives FDA Approval for AKLIEF® (trifarotene) Cream ...Oct 7, 2019 · Trifarotene is the first new retinoid molecule to receive U.S. FDA approval for the treatment of acne in more than 20 years.4,5,6 AKLIEF Cream ...
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[8]
Long‐term safety and efficacy of trifarotene 50 μg/g cream, a first‐in ...In this 52‐week study, trifarotene was safe, well tolerated and effective in moderate facial and truncal acne.Missing: PERSEUS | Show results with:PERSEUS
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[9]
Search Orphan Drug Designations and Approvals - FDAGeneric Name: trifarotene. Date Designated: 06/06/2014. Orphan Designation: Treatment of congenital ichthyosis. Orphan Designation Status: Designated.
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[10]
A Real-World Approach to Trifarotene Treatment in Patients with ...Jan 9, 2025 · At 12 weeks, the success rates for facial acne were significantly higher in trifarotene vs vehicle recipients (29.4% vs 19.5% in PERFECT 1 and ...Commentary · Trifarotene: Pharmacology · Trifarotene In Personalised...<|control11|><|separator|>
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[11]
Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A ...Oct 15, 2023 · Trifarotene was effective and well tolerated in treating moderate-to-severe facial acne and reducing atrophic acne scars, with reduction of total atrophic scar ...
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[12]
A Randomized, Controlled Trial of Trifarotene Plus Doxycycline for ...The combination of trifarotene plus oral doxycycline was a safe and effective treatment regimen in subjects with severe acne, and was significantly superior ...
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[13]
[PDF] Multi-Discipline Review - accessdata.fda.govOct 3, 2019 · Comprehensive Clinical Pharmacology Review ... Review of Carcinogenicity Studies Conducted With Trifarotene .................. 147. OCP ...
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[14]
Nonclinical and human pharmacology of the potent and ... - PubMedJul 4, 2018 · Results: Trifarotene is a selective RARγ agonist with > 20-fold selectivity over RARα and RARβ. Trifarotene is active and stable in ...Missing: mechanism action EC50
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[15]
Safety and efficacy of trifarotene in treatment of acne | TCRMJul 26, 2021 · A 52-week, open-label, noncomparative trial was conducted concurrently with the PERFECT trials from 2015–2017 at multiple US and European sites.
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[16]
Trifarotene: First Approval - PubMedTopical trifarotene (Aklief®) is a first-in-class, fourth-generation retinoid [selective retinoic acid receptor (RAR)-γ agonist] being developed by Galderma ...
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[17]
Clinical Pharmacology and Safety of Trifarotene, a First‐in‐Class ...Trifarotene represents a new generation of retinoids and is the first‐in‐class drug developed for the treatment of acne on both the face and trunk in patients 9 ...
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[18]
Trifarotene: Uses, Interactions, Mechanism of Action - DrugBankOct 21, 2016 · Trifarotene is a potent and selective agonist of retinoic acid receptor-γ (RAR-γ). It has significantly less activity at RAR-β and RAR-α (16- and 65-fold lower ...Identification · Pharmacology · Categories · References
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[19]
[PDF] NDA Multidisciplinary Review and Evaluation - accessdata.fda.govOct 12, 2018 · Trifarotene was evaluated for effects on embryofetal development in a study that involved administration by oral gavage to female rats on ...
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[20]
TRIFAROTENE - gsrsChemical Structure ; Stereochemistry. ACHIRAL ; Molecular Formula. C29H33NO ; Molecular Weight. 459.58 ; Optical Activity. NONE ; Defined Stereocenters. 0 / 0.
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[21]
[PDF] Product Quality Review(s) - accessdata.fda.govSep 5, 2019 · Cbn41 The API has been shown to be stable for 60 months under the long-term stability conditiOJ}ti> of 25°C/60%RH and therefore, has been ...
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[22]
[PDF] Attachment: Product Information for TrifaroteneMar 18, 2021 · low systemic exposure, with a short terminal half-life ranging from 2.4 to 9.1 hours and ... drug to be eliminated and 7 half-lives for about 99% ...
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[23]
Structure-based design of Trifarotene (CD5789), a potent ... - PubMedJun 1, 2018 · A novel triaryl series of agonists which was optimized and ultimately led to the discovery of Trifarotene/CD5789.
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Structure-based design of Trifarotene (CD5789), a potent and ...CD5789, a potent and selective γ-selective RAR agonist is in Phase 3 clinical trials for the topical treatment of acne.
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[26]
Clinical Pharmacology and Safety of Trifarotene, a First-in ... - PubMedResults showed that trifarotene 50 µg/g cream is well tolerated and safe, even when applied under maximized conditions in adults and pediatric acne patients ...<|control11|><|separator|>
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Trifarotene | Drug Lookup | Pediatric Care Online - AAP PublicationsCanadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to trifarotene or any component of the formulation or container; ...
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Trifarotene for acne - Australian PrescriberAug 2, 2021 · In the PERFECT trials, most adverse events were mild with transient local irritation consistent with other topical retinoids, with mild–moderate ...Missing: PERSEUS | Show results with:PERSEUS
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[29]
Union Register of medicinal products - Public health - EC EuropaJun 30, 2025 · Designation number: EU/3/20/2264. Active substance: Trifarotene. Indication: Treatment of autosomal recessive congenital ichthyosis.
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Clinical Pharmacology and Safety of Trifarotene, a First‐in‐Class ...Feb 3, 2020 · Ethinyl estradiol is metabolized to various hydroxylated metabolites and their glucuronide and sulfate conjugates via cytochrome P450 (CYP) 3A4 ...Missing: hydroxy- | Show results with:hydroxy-<|control11|><|separator|>
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[31]
Dose Range Study of CD5789 in Acne Vulgaris | ClinicalTrials.govTo assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.
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Galderma Announces Publication of Pivotal Phase 3 PERFECT 1 ...Mar 1, 2019 · "PERFECT 1 and PERFECT 2 are the first and only large-scale randomized trials to evaluate a topical retinoid for the treatment of both facial ...
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Study Details | NCT07186413 - ClinicalTrials.govSep 22, 2025 · A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris (AKLIEF).
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AKLIEF trifarotene 50 microgram/g cream bottle (332220)Jan 18, 2021 · Product name ... AKLIEF trifarotene 50 microgram/g cream bottle ... ARTG Date ... 18 January 2021 ... Registration Type ... Medicine ... Therapeutic good ...
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Aklief patent expiration - Pharsight - GreyBAklief is a drug owned by Galderma Laboratories Lp. It is protected by 5 US drug patents filed from 2019 to 2021 out of which none have expired yet.Missing: synthesis | Show results with:synthesis<|control11|><|separator|>
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[38]
Aklief - Therapeutic Goods Administration (TGA)Aklief (trifarotene) was approved for the following therapeutic use: Aklief is indicated for the topical treatment of Acne Vulgaris of the face and/or the trunk ...
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Generic Aklief Availability - Drugs.comOct 8, 2025 · Is there a generic version of Aklief available? No, there is currently no Aklief generic available in the United States.
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The Patient Savings Program for Patients - Galderma CareConnectThrough Galderma CAREConnect, eligible patients can get remarkable savings, paying as little as $0 on some Galderma prescription products filled at ...
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[41]
Patient Savings Card | AKLIEF® (trifarotene) CreamProduct Size: 45 g pump. covered. $20. not covered/cash. $90. *Certain ... This site is intended for U.S. audiences only. Information in this website ...
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[42]
Aklief (trifarotene) FDA Approval History - Drugs.comJan 27, 2021 · FDA Approved: Yes (First approved October 4, 2019) ; Brand name: Aklief ; Generic name: trifarotene ; Dosage form: Topical Cream ; Company: Galderma ...
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[43]
[PDF] Clinical Policy: Trifarotene (Aklief) - Ambetter HealthNov 26, 2019 · FDA Approved Indication(s). Aklief is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Policy/Criteria.
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Summary Basis of Decision for AkliefThe terminal half-life of trifarotene ranged from 2 to 9 hours in patients receiving once daily cutaneous application. No drug accumulation is expected with ...
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[45]
Buy Aklief 0.005% Cream 75g - Trifarotene Online at ePharmacy®... PBS safety net for the PBS prescriptions supplied. DISCOUNTED PBS PRICE. If you hold a Medicare Card and a valid PBS prescription you are entitled to receive ...
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Galderma receives a positive outcome through the European ...Dec 20, 2019 · Once approved, trifarotene 50 mcg/g cream will be the first new ... approval from Health Canada in November 2019.11. About Galderma.
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[47]
Trifarotene - WikiProjectMed - MDWiki.org... approval for 16 European countries. The current approval status in each of these 16 countries is unknown. References. ↑ ...<|separator|>
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[48]
MHLW Seeks Sponsor for Drug Loss Product TrifaroteneSep 4, 2025 · Japan's key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to… TRENDS · Top ...