Business Details
Innovative Liposomal Drug Delivery Solutions
Lipella Pharmaceuticals is a biotechnology company dedicated to transforming scientific breakthroughs into real-world medical solutions. Our proprietary liposomal drug delivery platform targets mucosal tissues with precision, addressing critical unmet needs in oncology, inflammation, and orphan diseases. With a focus on conditions like Oral Lichen Planus, Hemorrhagic Cystitis, and Graft-versus-Host Disease, we leverage decades of scientific expertise to develop therapies that maximize efficacy while minimizing systemic side effects.Our team collaborates with academic institutions, biotech leaders, and healthcare providers to advance treatments through accelerated development pathways, including the FDA's 505(b)(2) process. Backed by NIH-funded research and clinical trials, we are committed to delivering innovative therapies that improve patient outcomes and redefine standards of care.
Services
LP-10 Oral Lichen Planus
LP-10 Hemorrhagic Cystitis
LP-10 Oral Graft versus Host Disease
LP-50 Non-Muscle Invasive Bladder Cancer
Highlights and features
- We specialize in mucosal-targeted liposomal therapies for orphan diseases
- Our platform repurposes proven drugs through FDA 505(b)(2) pathways
- NIH-funded research supports clinical development in unmet medical needs
- We maintain active Phase 2 clinical trials for multiple indications
- Our team combines academic and industry expertise in drug delivery systems
Associations and certifications
- FDA Orphan Drug Designation
Services
LP-10 Oral Lichen Planus
Our LP-10 oral rinse targets Oral Lichen Planus, a chronic autoimmune condition affecting 6-7 million Americans. This FDA-approved investigational therapy delivers liposomal tacrolimus directly to damaged oral mucosa. Clinical trials demonstrate significant inflammation reduction and tissue healing while maintaining safety through localized action.
LP-10 Hemorrhagic Cystitis
We develop LP-10 intravesical treatments for Hemorrhagic Cystitis, a life-threatening bladder condition with 5% mortality. Our orphan-designated therapy provides targeted immunosuppression through liposomal delivery. Published Phase 2a results show efficacy in managing radiation-induced bladder damage without systemic toxicity.
LP-50 Non-Muscle Invasive Bladder Cancer
Our LP-50 formulation delivers intravesical PD-1 inhibitors for Non-Muscle Invasive Bladder Cancer. This checkpoint immunotherapy targets tumors directly while minimizing systemic exposure. Preclinical data presented at ASCO 2024 demonstrates potential for improved efficacy compared to traditional intravesical therapies.
Questions
What clinical trials are currently active at Lipella?
We are conducting Phase 2a trials for LP-10 in Oral Lichen Planus and have completed Phase 2a for Hemorrhagic Cystitis. IND was approved for Oral GvHD in March 2024.
What makes Lipella's drug delivery unique?
Our liposomal platform targets mucosal tissues with precision, enhancing drug retention while reducing systemic exposure. This enables repurposing of proven drugs through accelerated development pathways.
Are Lipella's treatments FDA approved?
Our therapies have received IND approval and Orphan Drug Designation. LP-10 for HC and OLP are in clinical trials, with LP-50 in preclinical development for bladder cancer.
How does Lipella address unmet medical needs?
We focus on orphan diseases with no approved therapies, including Hemorrhagic Cystitis and Oral Lichen Planus, where traditional treatments fail to provide effective, lasting solutions.
