Achelios Therapeutics
We are a clinical-stage biopharmaceutical company enabling localized non-systemic delivery of active compounds to patients, using our proprietary topical formulation platform Achetogel™
- We can provide localized drug delivery with superior efficacy and safety.
- Our platform can provide enhanced efficacy and safety of known and novel drugs.
- We have utilized our patented technology for the development of novel therapeutic entities for the treatment of conditions of high unmet medical need.
Our Strategy
By taking advantage of the 505(b)(2) regulatory pathway created by the U.S. Food and Drug Administration (“FDA”), we are able to combine generic and NCEs with our proprietary topical drug-delivery system to create significant improvement in therapy via enhanced and extended delivery of drug products.
- Accelerated drug development process
- Broad drug differentiation
- Lower development costs
- Best-in-Class Strategy
Clinical Development
The 505(b)(2) new drug application (“NDA”) process seeks FDA approval of a new drug based in part on data previously filed and reviewed by the FDA, including published literature references. Using this pathway can significantly reduce the future time and costs associated with clinical development.