Last reviewed · How we verify
Tri-Luma (HYDROQUINONE)
At a glance
| Generic name | HYDROQUINONE |
|---|---|
| Sponsor | Galderma Labs Lp |
| Drug class | Melanin Synthesis Inhibitor [EPC] |
| Target | Carbonic anhydrase 2 |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | FDA-approved |
| First approval | 2002 |
Approved indications
- Chloasma
- Discoloration of skin
- Facial Hyperpigmentation
Common side effects
- Dryness
- Fissuring of paranasal and infraorbital areas
- Erythema
- Stinging
Serious adverse events
- Hypersensitivity (localized contact dermatitis)
Key clinical trials
- A 16-week Clinical Study Investigating a Dark Spot Corrector Serum in Women With Moderate Discrete Hyperpigmentation (NA)
- Comparison of Efficacy of Metformin Gel 30% vs Triple Combination Cream (Hydroquinone 4%, Flucinolone Acetonide 0.01%, Tretinoin 0.025%) in Treatment of Melasma in Tertiary Care Hospital Karachi (NA)
- Azelaic Acid 20% vs Hydroquinone 4% in Epidermal Melasma (NA)
- Fractionated 1927nm Laser for Hyperpigmentation in Fitzpatrick Skin Phototypes V and VI (NA)
- Prospective Evaluation of Topical Almond Oil vs Hydroquinone (PHASE4)
- COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS (NA)
- Efficacy and Safety of a Combined Serum Containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES (NA)
- A Study to Assess Efficacy of Supporting Properties and Safety of ARTNEO in Patients With Knee Osteoarthritis (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tri-Luma CI brief — competitive landscape report
- Tri-Luma updates RSS · CI watch RSS
- Galderma Labs Lp portfolio CI