Aspire Biopharma
Early-stage biopharmaceutical company developing a patent-pending oral transmucosal (sublingual) delivery platform that produces fast-acting, soluble powder/granular dosage forms. The platform is intended to enable rapid systemic absorption, bypass first-pass hepatic metabolism and the gastrointestinal tract, and to be applied to approved drugs, nutraceuticals and supplements. Lead clinical program focuses on a high-dose, fast-absorbing sublingual aspirin formulation and the company pursues licensing, manufacturing partnerships and regulatory pathways (including a 505(b)(2) strategy) to support commercialization.
Industries
Nr. of Employees
small (1-50)
Aspire Biopharma
23150 Fashion Drive, Suite 232, Estero, FL 33928
Products
High-dose sublingual aspirin (lead therapeutic candidate)
A soluble, pH-neutral, fast-acting powder/granular aspirin formulation intended for sublingual administration to provide rapid systemic absorption for cardiology emergencies and acute pain management.
Single-dose sublingual pre-workout supplement (consumer product)
Clinically dosed single-serve sachet pre-workout format formulated for sublingual administration that includes caffeine and performance ingredients to provide on-the-go energy without mixing.
High-dose sublingual aspirin (lead therapeutic candidate)
A soluble, pH-neutral, fast-acting powder/granular aspirin formulation intended for sublingual administration to provide rapid systemic absorption for cardiology emergencies and acute pain management.
Single-dose sublingual pre-workout supplement (consumer product)
Clinically dosed single-serve sachet pre-workout format formulated for sublingual administration that includes caffeine and performance ingredients to provide on-the-go energy without mixing.
Services
Licensing of the company's sublingual delivery platform and formulation know-how to third-party pharmaceutical and nutraceutical companies.
Technical product development, formulation transfer and coordination with contract manufacturers for GMP batch preparation and scale-up.
Licensing of the company's sublingual delivery platform and formulation know-how to third-party pharmaceutical and nutraceutical companies.
Technical product development, formulation transfer and coordination with contract manufacturers for GMP batch preparation and scale-up.
Expertise Areas
- Sublingual drug delivery
- Formulation development for soluble powder/granular dosage forms
- Early-phase clinical trial conduct (Phase I PK/PD and safety)
- Analytical stability and solubility testing
Key Technologies
- Oral transmucosal (sublingual) delivery
- Soluble powder/granular formulation
- pH-neutral formulation chemistry
- Micelle-based delivery (patent filing referenced)
News & Updates
Initiation of a Phase I single-center clinical study to evaluate safety, pharmacokinetics and pharmacodynamics of a sublingual aspirin powder in healthy volunteers.
Centralized IRB approval was received for the Phase I single-dose study assessing safety and PK/PD of the oral transmucosal aspirin formulation.
Completed 3-month and 6-month stability studies confirming long-term stability and shelf-life characteristics for an aspirin-based sublingual test formulation as part of a development agreement with a contract development partner.
Announcement of a definitive agreement and plan of merger with a special purpose acquisition company to combine and list the combined public company, with stated intentions to use proceeds to accelerate development and commercialization.
Successful completion of 3- and 6-month stability and solubility testing for a test batch of sublingual aspirin formulation.
Received IRB approval for the Phase I single-center clinical protocol evaluating safety and PK/PD of a high-dose sublingual aspirin formulation.
Initiation of a Phase I single-center clinical study to evaluate safety, pharmacokinetics and pharmacodynamics of a sublingual aspirin powder in healthy volunteers.
Centralized IRB approval was received for the Phase I single-dose study assessing safety and PK/PD of the oral transmucosal aspirin formulation.
Completed 3-month and 6-month stability studies confirming long-term stability and shelf-life characteristics for an aspirin-based sublingual test formulation as part of a development agreement with a contract development partner.
Announcement of a definitive agreement and plan of merger with a special purpose acquisition company to combine and list the combined public company, with stated intentions to use proceeds to accelerate development and commercialization.
Successful completion of 3- and 6-month stability and solubility testing for a test batch of sublingual aspirin formulation.
Received IRB approval for the Phase I single-center clinical protocol evaluating safety and PK/PD of a high-dose sublingual aspirin formulation.