Lipella Pharmaceuticals
Clinical-stage biotechnology company focused on liposomal reformulations for local mucosal and intravesical delivery. Advanced multiple programs into IND-authorized, multicenter Phase 2 studies, developed intravesical MRI imaging methods, maintained an IP portfolio for imaging and delivery technologies, and coordinated CMC collaborations for clinical supply scale-up. The company filed for Chapter 11 in March 2026, submitted Monthly Operating Reports to the bankruptcy court documenting cash balances, payroll accruals, and a disclosed clinical supply inventory that requires release testing, and completed a court-approved sale of development programs and related assets in June 2026. The corporate website is maintained as an archival source of public disclosures.
Industries
Nr. of Employees
small (1-50)
Lipella Pharmaceuticals
Pittsburgh, Pennsylvania, United States, North America
Patents
Products
Liposomal tacrolimus oral rinse (clinical-stage)
Sterile lyophilized liposomal tacrolimus formulated for reconstitution as a 10 mL oral rinse administered for local treatment of oral mucosal disease; evaluated in multicenter Phase 2a studies with reported favorable safety and low systemic absorption. Remaining clinical supply was disclosed in bankruptcy filings and requires batch release testing (sterility, drug content, lipid content, residual solvent) prior to further use.
Liposomal tacrolimus intravesical formulation (clinical-stage)
Sterile intravesical liposomal tacrolimus intended for instillation and defined dwell time in the bladder, evaluated in Phase 2a dose‑escalation studies for hemorrhagic cystitis with evidence of localized effect and low transient systemic exposure. Clinical supply inventories were disclosed in court filings and remain subject to required release testing.
LP-10
LP-10 is a liposomal tacrolimus formulation developed for the treatment of hemorrhagic cystitis, a serious bladder condition caused by pelvic radiation therapy and/or bladder-toxic chemotherapy. It has completed a Phase 2a clinical trial and received FDA Orphan Designation.
LP-10 (Oral Rinse)
LP-10 is a liposomal tacrolimus oral rinse being developed for the treatment of Oral Lichen Planus (OLP), a chronic, inflammatory, T-cell-mediated autoimmune oral mucosal disease. It is currently in clinical trials including Phase 2a multicenter, dose-ranging studies.
LP-50 (Intravesical)
LP-50 is an intravesical formulation for local, intravesical PD-1 (checkpoint) inhibition, intended for the treatment of non muscle invasive bladder cancer (NMIBC).
Intravesical Liposomal Tacrolimus
A liposomal tacrolimus formulation for intravesical use in hemorrhagic cystitis, developed by Lipella Pharmaceuticals and studied in FDA-authorized clinical trials.
Liposomal tacrolimus oral rinse (clinical-stage)
Sterile lyophilized liposomal tacrolimus formulated for reconstitution as a 10 mL oral rinse administered for local treatment of oral mucosal disease; evaluated in multicenter Phase 2a studies with reported favorable safety and low systemic absorption. Remaining clinical supply was disclosed in bankruptcy filings and requires batch release testing (sterility, drug content, lipid content, residual solvent) prior to further use.
Liposomal tacrolimus intravesical formulation (clinical-stage)
Sterile intravesical liposomal tacrolimus intended for instillation and defined dwell time in the bladder, evaluated in Phase 2a dose‑escalation studies for hemorrhagic cystitis with evidence of localized effect and low transient systemic exposure. Clinical supply inventories were disclosed in court filings and remain subject to required release testing.
LP-10
LP-10 is a liposomal tacrolimus formulation developed for the treatment of hemorrhagic cystitis, a serious bladder condition caused by pelvic radiation therapy and/or bladder-toxic chemotherapy. It has completed a Phase 2a clinical trial and received FDA Orphan Designation.
LP-10 (Oral Rinse)
LP-10 is a liposomal tacrolimus oral rinse being developed for the treatment of Oral Lichen Planus (OLP), a chronic, inflammatory, T-cell-mediated autoimmune oral mucosal disease. It is currently in clinical trials including Phase 2a multicenter, dose-ranging studies.
LP-50 (Intravesical)
LP-50 is an intravesical formulation for local, intravesical PD-1 (checkpoint) inhibition, intended for the treatment of non muscle invasive bladder cancer (NMIBC).
Intravesical Liposomal Tacrolimus
A liposomal tacrolimus formulation for intravesical use in hemorrhagic cystitis, developed by Lipella Pharmaceuticals and studied in FDA-authorized clinical trials.
Expertise Areas
- Liposomal drug formulation for mucosal and intravesical delivery
- Early‑phase clinical trial management (multicenter, dose‑ranging, Phase 2a)
- Local intravesical and oral mucosal biologic delivery
- Preclinical bladder cancer and cystitis models
Key Technologies
- Liposomal encapsulation for local delivery
- Intravesical instillation delivery methods
- Oral mucosal rinse administration
- Liquid chromatography–tandem mass spectrometry (LC–MS/MS) bioanalysis
News & Updates
Completion of a court-approved sale of development programs, associated intellectual property, regulatory assets, clinical data, and drug product inventory; company concluded research and development activities.
Company filed voluntary petitions for relief under Chapter 11 and initiated a 363 sale process; first‑day relief and related bankruptcy procedures were undertaken to preserve estate value.
Monthly Operating Report filed with the bankruptcy court summarizing cash receipts and disbursements, bank reconciliations, payroll accruals, balance sheet, and postpetition liabilities for period ending 05/31/2026; report disclosed cash end-of-period book and bank balances and postpetition payroll tax liabilities.
Monthly Operating Report and supporting bank statements filed reporting cash activity, balance sheet, and inventory disclosure for period ending 04/30/2026.
Initial Monthly Operating Report following the Chapter 11 petition documenting opening cash position, receipts, disbursements, and accrued payroll as of 03/31/2026.
Announcement of determination by Nasdaq Hearings Panel to delist the company’s common stock, with trading subsequently suspended and securities quoted on OTC Markets.
Completion of a court-approved sale of development programs, associated intellectual property, regulatory assets, clinical data, and drug product inventory; company concluded research and development activities.
Company filed voluntary petitions for relief under Chapter 11 and initiated a 363 sale process; first‑day relief and related bankruptcy procedures were undertaken to preserve estate value.
Monthly Operating Report filed with the bankruptcy court summarizing cash receipts and disbursements, bank reconciliations, payroll accruals, balance sheet, and postpetition liabilities for period ending 05/31/2026; report disclosed cash end-of-period book and bank balances and postpetition payroll tax liabilities.
Monthly Operating Report and supporting bank statements filed reporting cash activity, balance sheet, and inventory disclosure for period ending 04/30/2026.
Initial Monthly Operating Report following the Chapter 11 petition documenting opening cash position, receipts, disbursements, and accrued payroll as of 03/31/2026.
Announcement of determination by Nasdaq Hearings Panel to delist the company’s common stock, with trading subsequently suspended and securities quoted on OTC Markets.