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Azelex (AZELAIC ACID)
Azelex works by inhibiting the enzyme 3-oxo-5-alpha-steroid 4-dehydrogenase 2, which is involved in the production of androgens that contribute to acne and rosacea.
Azelex (Azelaic Acid) is a small molecule drug originally developed by Allergan and currently owned by Leo Pharma A/S. It targets the enzyme 3-oxo-5-alpha-steroid 4-dehydrogenase 2 and is used to treat acne vulgaris and rosacea. Azelex is classified as an azelaic acid and was FDA-approved in 1995. It is now off-patent with multiple generic manufacturers available. As an off-patent medication, Azelex is widely available in the market.
At a glance
| Generic name | AZELAIC ACID |
|---|---|
| Sponsor | Leo Pharma As |
| Drug class | azelaic acid |
| Target | 3-oxo-5-alpha-steroid 4-dehydrogenase 2 |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
| First approval | 1995 |
Mechanism of action
The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.
Approved indications
- Acne vulgaris
- Rosacea
Common side effects
- Burning/stinging/tingling
- Pruritus
- Scaling/dry skin/xerosis
- Erythema/irritation
- Edema
- Acne
- Contact dermatitis
- Iridocyclitis
- Worsening of asthma
- Vitiligo depigmentation
- Small depigmented spots
- Hypertrichosis
Key clinical trials
- Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA) (EARLY_PHASE1)
- Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation (PHASE1)
- Azelaic Acid 20% vs Hydroquinone 4% in Epidermal Melasma (NA)
- Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne (PHASE4)
- To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel (PHASE1)
- A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily (PHASE4)
- A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face (PHASE2)
- A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 10117812 | 2027-10-18 | Formulation |
| 9211259 | 2029-02-28 | Method of Use |
| 9265725 | 2027-12-08 | Formulation |
| 7700076 | 2027-09-18 | Formulation |
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:
- Azelex CI brief — competitive landscape report
- Azelex updates RSS · CI watch RSS
- Leo Pharma As portfolio CI