What Lipella Pharmaceuticals does

Lipella Pharmaceuticals is a clinical-stage biotechnology company developing drug reformulations based on a proprietary liposomal delivery platform engineered for mucosal surfaces. Its lead candidate, LP-10 (liposomal tacrolimus), is being evaluated across three indications: oral lichen planus (oral rinse), hemorrhagic cystitis (intravesical), and oral graft-versus-host disease (oral rinse). LP-50, an intravesical liposomal PD-1 checkpoint inhibitor for non-muscle invasive bladder cancer, extends the platform into immuno-oncology. The company pursues the FDA 505(b)(2) pathway, has received Orphan Drug Designations for LP-10 in hemorrhagic cystitis and oral GvHD, and has IND approvals for Phase 2a trials in OLP and oral GvHD.

The company is headquartered in Pittsburgh, Pennsylvania, employs 1–10 people, and is led by CEO Jonathan Kaufman, PhD, with co-founder Michael Chancellor serving as Chief Medical Officer. Lipella went public on Nasdaq in December 2022 and was delisted in June 2025 due to noncompliance; it currently trades on OTC under ticker LIPO. Between October 2023 and March 2025, the company completed four small private placements (with H.C. Wainwright and Spartan Capital Securities) and secured a $1.35M SBIR grant from NIDDK, cumulatively raising roughly $8.4M plus grant funding.

Lipella is pre-revenue with no commercial products and has no disclosed customers; the planned commercial model contemplates specialty pharmacy and hospital formulary distribution upon FDA approval. In March 2026, the company filed for Chapter 11 bankruptcy in the U.S. Bankruptcy Court for the Western District of Pennsylvania, citing an inability to secure adequate funding, and announced plans to pursue a 363 sale process. A manufacturing collaboration with Cook MyoSite and patient registry programs for radiation cystitis and OLP reflect clinical infrastructure investments prior to the bankruptcy filing.

Name

Lipella Pharmaceuticals

Legal name

Lipella Pharmaceuticals Inc.

Website

https://lipella.com

Company type

Public

Founded year

2022

Operating status

Closed

Headcount range

1–10 employees

Short description

Lipella Pharmaceuticals is a pre-revenue, clinical-stage biotechnology company developing liposomal drug reformulations (LP-10 tacrolimus, LP-50 PD-1 inhibitor) for mucosal diseases including oral lichen planus, hemorrhagic cystitis, and bladder cancer, which filed for Chapter 11 bankruptcy in March 2026.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Dermatology Specialty Pharmaceuticals (HLAIACAL)

akta.pro secondary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

Keywords

• Liposomal drug delivery
• Clinical-stage biotechnology
• Intravesical therapy
• Mucosal drug delivery
• 505(b)(2) drug reformulation

Headquarters

HQ city

Pittsburgh

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Supply Chain, Others

Revenue model

1. Pharmaceutical Product Sales: Pre-revenue clinical-stage company planning to commercialize drug candidates through traditional pharmaceutical distribution channels upon FDA approval

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

Lipella Pharmaceuticals is a clinical-stage biotechnology company developing proprietary liposomal drug delivery formulations for mucosal surface diseases. Its lead candidate LP-10 is a liposomal tacrolimus formulation being developed as an oral rinse for oral lichen planus and oral graft-versus-host disease, and as an intravesical therapy for hemorrhagic cystitis. Its second candidate LP-50 is an intravesical liposomal PD-1 checkpoint inhibitor for non-muscle invasive bladder cancer. The company is also developing an MRI contrast agent for bladder disease diagnosis. Lipella pursues FDA approval via the 505(b)(2) pathway by reformulating proven drugs with novel mucosal delivery methods.

Product overview

Lipella Pharmaceuticals is a clinical-stage biotechnology company with a proprietary liposomal drug delivery platform designed for targeted mucosal surface delivery. The company is developing multiple drug candidates: LP-10, a liposomal tacrolimus formulation being evaluated in three indications (oral lichen planus as an oral rinse, hemorrhagic cystitis as an intravesical therapy, and oral graft-versus-host disease as an oral rinse), and LP-50, an intravesical formulation using PD-1 checkpoint inhibitors for bladder cancer. The platform enables localized drug delivery to mucosal tissues including the bladder, oral cavity, urethra, esophagus, and colon, allowing for targeted treatment while minimizing systemic side effects. The company utilizes the 505(b)(2) regulatory pathway for accelerated development by repurposing proven drugs with new delivery methods.

Differentiator

Problem solved

Functional benefit

Products and services

• LP-10 Oral Rinse (Oral Lichen Planus) Liposomal tacrolimus oral rinse formulation intended for the treatment of oral lichen planus (OLP), a chronic, painful, inflammatory, pre-malignant autoimmune disease affecting oral mucous membranes in approximately 6-7 million Americans with no FDA-approved therapy.
• LP-10 Intravesical (Hemorrhagic Cystitis) Bladder-delivered (intravesical) formulation of liposomal tacrolimus intended for the treatment of moderate to severe hemorrhagic cystitis, a serious life-threatening bladder condition with no FDA-approved treatments.
• LP-10 Oral Rinse (Oral Graft-versus-Host Disease) Liposomal tacrolimus oral rinse targeting chronic oral graft-versus-host disease (GvHD), a rare, life-threatening complication following bone marrow transplant. FDA Orphan Drug Designation granted.
• LP-50 Intravesical (Non-Muscle Invasive Bladder Cancer) Novel intravesical immunotherapy using liposomal PD-1 checkpoint inhibitors for the treatment of non-muscle invasive bladder cancer, designed to deliver localized immunotherapy directly to tumors and reduce systemic toxicity.
• MRI Contrast Agent for Bladder Disease Diagnosis Diagnostic MRI contrast agent designed to identify bladder wall defects, bladder tumor progression, and interstitial cystitis/bladder pain syndrome.

Quantifiable outcome

• Positive Phase 2a results for LP-10 in hemorrhagic cystitis published in International Urology and Nephrology
• +2 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Cook MyoSitecoreStrategic or Co-development Partner · 15 June 2025Manufacturing collaboration agreement re-signed to support LP-310 clinical development. Cook MyoSite provides manufacturing capabilities for clinical supply.

Scale indicators9 records

Recent moves7 records

Expansion highlights4 records

Broad incumbents

• Merck & Co. Merck's Keytruda (pembrolizumab) is approved for BCG-unresponsive NMIBC and is the dominant PD-1 checkpoint inhibitor. Broad incumbent given that LP-50 is a localized PD-1 delivery approach positioned as a lower-toxicity alternative to systemic checkpoint blockade.
• Ferring Pharmaceuticals: Ferring received FDA approval for Adstiladrin (nadofaragene firadenovec) for high-grade BCG-unresponsive NMIBC. Broad incumbent offering a competing intravesical NMIBC therapy that competes with Lipella's LP-50 in the same patient setting.
• Bristol-Myers Squibb: BMS markets Opdivo (nivolumab), another leading PD-1 checkpoint inhibitor. Broad incumbent given that LP-50's mechanism (intravesical PD-1 inhibitor) directly competes with systemic PD-1 blockade in NMIBC.
• Astellas Pharma: Astellas markets Valstar (valrubicin) for BCG-refractory NMIBC and is a longstanding incumbent in urologic oncology. Broad incumbent given comparable bladder cancer franchise and distribution scale that any acquirer of Lipella's LP-50 would need to compete with.

Emerging players

• CG Oncology: CG Oncology is developing cretostimogene, an intravesical oncolytic immunotherapy for BCG-unresponsive NMIBC. Emerging player with a directly overlapping intravesical NMIBC immunotherapy strategy that competes with Lipella's LP-50 in the same patient population.
• Protara Therapeutics: Protara is a clinical-stage urology-focused biotech developing therapies for NMIBC and lymphatic malformations. Emerging player with overlapping urology focus and similar clinical-stage, single-indication development profile to Lipella.

Direct peers

• Nektar Therapeutics: Nektar developed polymer-conjugate drug delivery platforms (e.g., NKTR-214, NKTR-181) to enhance pharmacology of existing molecules. Direct peer given shared model of platform-based drug reformulation to improve targeting and tolerability of validated payloads.
• Lipocine: Lipocine is a clinical-stage specialty pharma using lipid-based oral delivery technology to reformulate existing drugs with improved bioavailability. Direct peer given shared strategy of repurposing approved molecules through novel delivery systems and 505(b)(2)-style regulatory pathways.
• Bio-Path Holdings: Bio-Path develops liposome-based DNA and RNAi drug delivery technology for cancer and other diseases. Direct peer given its analogous liposomal delivery platform architecture targeting oncology indications, including pre-clinical and clinical programs.
• ImmunityBio: ImmunityBio's Anktiva (nogapendekin alfa) is an FDA-approved intravesical immunotherapy for NMIBC. Direct peer given Lipella's LP-50 intravesical PD-1 inhibitor targets the same non-muscle invasive bladder cancer setting using a localized immunotherapy approach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/LipellaPharma
• LinkedInlinkedin.com/company/lipella-pharmaceuticals

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds9 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Lipella Pharmaceuticals