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CD5789 (trifarotene)
CD5789 (trifarotene) is a Selective retinoid X receptor (RXR) agonist Small molecule drug developed by Galderma R&D. It is currently in Phase 3 development for Psoriasis, Atopic dermatitis.
Trifarotene is a selective retinoid X receptor (RXR) agonist that modulates gene expression to reduce inflammation and promote skin cell differentiation.
Trifarotene, also known as CD5789, is a small molecule that acts as a retinoic acid receptor gamma agonist. It is being studied as a treatment for Acne Vulgaris, specifically in a clinical trial comparing its efficacy and safety when used with an oral antibiotic.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | CD5789 (trifarotene) |
|---|---|
| Sponsor | Galderma R&D |
| Drug class | Selective retinoid X receptor (RXR) agonist |
| Target | Retinoid X receptor (RXR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Trifarotene selectively activates retinoid X receptors (RXR), which are nuclear receptors involved in regulating inflammatory pathways and keratinocyte differentiation. By binding to RXR, the drug modulates transcription of genes involved in skin inflammation and barrier function, making it effective for inflammatory skin conditions. This selective RXR mechanism differs from traditional retinoids by offering potentially improved tolerability with reduced off-target effects.
Approved indications
- Psoriasis
- Atopic dermatitis
Common side effects
- Skin irritation
- Headache
- Nasopharyngitis
Key clinical trials
- A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris (PHASE3)
- Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation (PHASE4)
- AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation (PHASE4)
- A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis (PHASE2)
- A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV) (PHASE4)
- Dose Range Study of CD5789 in Acne Vulgaris (PHASE2)
- CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris (PHASE3)
- Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CD5789 (trifarotene) CI brief — competitive landscape report
- CD5789 (trifarotene) updates RSS · CI watch RSS
- Galderma R&D portfolio CI
Frequently asked questions about CD5789 (trifarotene)
What is CD5789 (trifarotene)?
How does CD5789 (trifarotene) work?
What is CD5789 (trifarotene) used for?
Who makes CD5789 (trifarotene)?
What drug class is CD5789 (trifarotene) in?
What development phase is CD5789 (trifarotene) in?
What are the side effects of CD5789 (trifarotene)?
What does CD5789 (trifarotene) target?
Related
- Drug class: All Selective retinoid X receptor (RXR) agonist drugs
- Target: All drugs targeting Retinoid X receptor (RXR)
- Manufacturer: Galderma R&D — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Psoriasis
- Indication: Drugs for Atopic dermatitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing