Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing treatments for serious diseases, with proprietary drug delivery technology targeting mucosal tissues such as the bladder, urethra, oral cavity, esophagus, and colon. The company focuses on developing proprietary 505(b)(2) assets for highly-morbid conditions with no adequate treatments, and maintains a sterile manufacturing facility in Pittsburgh, PA.
Industries
Nr. of Employees
small (1-50)
Lipella Pharmaceuticals Inc.
Pittsburgh, Pennsylvania, United States, North America
Products
Intravesical liposomal tacrolimus formulation for hemorrhagic cystitis (Phase 2a completed)
A liposomal intravesical formulation developed for hemorrhagic cystitis; completed a Phase 2a multi-center dose-escalation trial with results reported in a peer-reviewed journal.
Topical liposomal formulation for oral lichen planus (Phase 2a positive topline results)
A liposomal topical therapy developed for oral lichen planus with positive topline Phase 2a results.
Liposomal therapy candidate for oral graft-versus-host disease (orphan designation)
A liposomal formulation under development for oral graft-versus-host disease that has received orphan drug designation.
Liposomal intravesical candidate for non-muscle invasive bladder cancer (development stage)
A liposomal intravesical product candidate in the company pipeline targeting non-muscle invasive bladder cancer.
Intravesical liposomal tacrolimus formulation for hemorrhagic cystitis (Phase 2a completed)
A liposomal intravesical formulation developed for hemorrhagic cystitis; completed a Phase 2a multi-center dose-escalation trial with results reported in a peer-reviewed journal.
Topical liposomal formulation for oral lichen planus (Phase 2a positive topline results)
A liposomal topical therapy developed for oral lichen planus with positive topline Phase 2a results.
Liposomal therapy candidate for oral graft-versus-host disease (orphan designation)
A liposomal formulation under development for oral graft-versus-host disease that has received orphan drug designation.
Liposomal intravesical candidate for non-muscle invasive bladder cancer (development stage)
A liposomal intravesical product candidate in the company pipeline targeting non-muscle invasive bladder cancer.
Services
Sterile manufacturing for clinical supplies
Production of sterile clinical and research materials in an on-site facility for use in clinical studies and research.
Patient registry design and management
Design, deployment, and maintenance of condition-specific patient registries aligned with NIH RaDaR guidance for data aggregation, trend analysis, and study recruitment.
Clinical trial design and management (early phase)
Design and execution of early-phase clinical studies including dose-escalation and multi-center Phase 2a trials.
Sterile manufacturing for clinical supplies
Production of sterile clinical and research materials in an on-site facility for use in clinical studies and research.
Patient registry design and management
Design, deployment, and maintenance of condition-specific patient registries aligned with NIH RaDaR guidance for data aggregation, trend analysis, and study recruitment.
Clinical trial design and management (early phase)
Design and execution of early-phase clinical studies including dose-escalation and multi-center Phase 2a trials.
Expertise Areas
- Mucosal-targeted drug development
- Liposomal formulation development
- Phase 2a clinical trial management
- Sterile GMP clinical manufacturing
Key Technologies
- Liposomal formulations
- Mucosal-targeted drug delivery
- Sterile GMP manufacturing
- Multi-center clinical trial platforms (dose-escalation design)