Lipella Pharmaceuticals is a clinical-stage biotech developing reformulated versions of tacrolimus, an existing FDA-approved generic immunosuppressant, delivered via a proprietary liposomal drug delivery platform, to treat rare diseases with no current FDA-approved therapies. Rather than discovering new chemical entities, Lipella reformulates tacrolimus for local delivery to specific body cavities — the bladder and mouth — targeting conditions where no approved treatment exists. This approach lets Lipella use the FDA's 505(b)(2) regulatory pathway, referencing existing tacrolimus safety data to reduce development cost and time. Lipella's lead program, LP-10, is an intravesical (bladder-instilled) formulation targeting hemorrhagic cystitis in cancer survivors, with a Phase 2a trial showing responses in 10 of 13 subjects. LP-310 is an oral rinse formulation targeting oral lichen planus, currently in Phase 2a. LP-410 is an oral rinse formulation targeting oral graft-versus-host disease, with IND approval received in early 2024. LP-50 is a preclinical intravesical formulation targeting bladder cancer. LP-10 and LP-410 hold FDA orphan drug designations, which provide seven years of marketing exclusivity upon approval. Lipella is pre-revenue and funds operations through equity financing. The company operates a small in-house manufacturing facility in Pittsburgh and intends to retain full commercialization rights, though it may pursue partnerships opportunistically.