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HLK-5002
- Development stage
- Unknown
- Lead developer
- Pharmacin International
- Modality
- Small Molecules
- Administration
- Topical
01
Overview
HLK-5002 is a topical small molecule formulation of the phosphodiesterase 4 (PDE4) inhibitor apremilast, currently under development by Pharmacin International for the treatment of psoriasis. Utilizing the FDA's 505(b)(2) regulatory pathway, HLK-5002 is designed to repurpose the established efficacy of apremilast—originally approved as an oral systemic therapy—into a localized topical treatment. This approach aims to provide targeted relief for psoriatic plaques while significantly reducing the systemic exposure and associated gastrointestinal side effects often linked to oral PDE4 inhibition. As of early 2024, the candidate has successfully completed Phase 1a clinical trials, demonstrating its safety and pharmacokinetic profile for further development.
- Other names
- Topical apremilast
02
Targets
PDE4 (Phosphodiesterase 4A1)
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