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Protopic® ointment, 0.1%
Protopic ointment, 0.1% works by inhibiting the transcription factor nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) to reduce inflammation.
Protopic ointment, 0.1% works by inhibiting the transcription factor nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) to reduce inflammation. Used for Atopic dermatitis, Severe psoriasis.
At a glance
| Generic name | Protopic® ointment, 0.1% |
|---|---|
| Sponsor | Glenmark Pharmaceuticals Ltd. India |
| Drug class | calcineurin inhibitor |
| Target | calcineurin |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
This is achieved through the inhibition of calcineurin, a protein phosphatase that dephosphorylates and activates NF-κB. By inhibiting NF-κB, Protopic ointment reduces the expression of pro-inflammatory genes, thereby decreasing inflammation. This mechanism of action is particularly useful in treating skin conditions characterized by inflammation.
Approved indications
- Atopic dermatitis
- Severe psoriasis
Common side effects
- Skin burning sensation
- Skin itching
- Skin redness
- Skin irritation
Key clinical trials
- Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children (NA)
- Comparison of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® Ointment 0.1% in Treating Atopic Dermatitis (PHASE2)
- Efficacy and Safety of a 0.1% Tacrolimus Nasal Ointment as a Treatment for Epistaxis in Hemorrhagic Hereditary Telangiectasia (HHT) (PHASE2)
- To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin) (PHASE3)
- A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test (PHASE1)
- Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis (PHASE3)
- Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment (PHASE3)
- Protopic Ointment in Adult Atopic Eczema of the Face (PHASE4)
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 |