Aisa Pharma Inc.
Aisa Pharma is a late-stage, clinical development company dedicated to bringing new treatments to patients with severe autoimmune and vascular diseases, focusing on repurposing existing drugs like calcium channel blockers to treat rare diseases such as Systemic Sclerosis and Raynaud’s Phenomenon. The company is engaged in clinical trials and has received FDA orphan drug designation for its lead drug candidate, AISA-021.
Industries
Nr. of Employees
small (1-50)
Aisa Pharma Inc.
Boston, Massachusetts, United States, North America
Products
Repurposed oral cilnidipine candidate for systemic sclerosis and secondary Raynaud’s
An oral, once-daily cilnidipine-based small-molecule candidate being developed to treat secondary Raynaud’s in patients with systemic sclerosis; being evaluated alone and in combination with a PDE5 inhibitor.
Repurposed oral cilnidipine candidate for systemic sclerosis and secondary Raynaud’s
An oral, once-daily cilnidipine-based small-molecule candidate being developed to treat secondary Raynaud’s in patients with systemic sclerosis; being evaluated alone and in combination with a PDE5 inhibitor.
Services
Clinical development program management
Management and execution of clinical development activities for an internal small-molecule candidate, including trial design, site selection, enrollment oversight, and DSMB coordination.
Preclinical pharmacology and safety assessment
Conduct and coordination of preclinical studies including pharmacology, abuse-potential assessment, and pharmacokinetic profiling.
Regulatory strategy and interactions
Preparation for and engagement with regulatory authorities to obtain orphan designation and plan for IND/NDA filings and related incentives.
Clinical development program management
Management and execution of clinical development activities for an internal small-molecule candidate, including trial design, site selection, enrollment oversight, and DSMB coordination.
Preclinical pharmacology and safety assessment
Conduct and coordination of preclinical studies including pharmacology, abuse-potential assessment, and pharmacokinetic profiling.
Regulatory strategy and interactions
Preparation for and engagement with regulatory authorities to obtain orphan designation and plan for IND/NDA filings and related incentives.
Expertise Areas
- Clinical trial management
- Drug repurposing for small molecules
- Orphan drug regulatory strategy
- Preclinical pharmacology and PK
Key Technologies
- Ion channel-targeting small molecules (calcium channel modulation)
- PDE5 inhibition
- Oral small-molecule therapeutics
- Randomized double-blind crossover trial design