tacrolimus liposomal (LP-10) / Lipella Pharma - LARVOL DELTA

Safety and Efficacy of LP-10 Liposomal Tacrolimus in Oral Lichen Planus: A Multicenter Phase 2 Trial. (PubMed, Dermatol Ther (Heidelb)) - P2 | "LP-10 demonstrated excellent safety with minimal systemic absorption and clinically meaningful efficacy, representing substantial improvement over existing therapies for this serious condition with significant unmet medical need. Larger controlled studies are warranted to confirm these promising findings."

Journal • P2 data • Dermatology • Dermatopathology • Lichen Planus • Pain

Lipella Pharmaceuticals Re-signs Manufacturing Collaboration Agreement with Cook MyoSite to Support LP-310 Clinical Development (GlobeNewswire) - "Lipella Pharmaceuticals Inc...today announced that it has re-signed its manufacturing collaboration agreement with Cook MyoSite, Inc...to support Chemistry, Manufacturing and Control (CMC) documentation supporting our clinical products LP-10 and LP-310."

Commercial • Lichen Planus

Evaluating LP-10 in Subjects With OLP (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Lipella Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2026 ➔ Jun 2025 | Trial primary completion date: Sep 2025 ➔ Jun 2025

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Dermatopathology • Lichen Planus

Evaluating LP-10 in Subjects With OLP (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Lipella Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2024 ➔ Jul 2024

Enrollment open • Trial initiation date • Dermatology • Dermatopathology • Lichen Planus

Evaluating LP-10 in Subjects With OLP (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Lipella Pharmaceuticals, Inc.

New P2 trial • Dermatology • Dermatopathology • Lichen Planus

The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis (clinicaltrials.gov) - P2 | N=13 | Completed | Sponsor: Lipella Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed | Trial completion date: May 2023 ➔ Sep 2023 | Trial primary completion date: Jan 2023 ➔ Aug 2023

Trial completion • Trial completion date • Trial primary completion date • Hematological Disorders

Intravesical liposomal tacrolimus for hemorrhagic cystitis: a phase 2a multicenter dose-escalation study. (PubMed, Int Urol Nephrol) - "LP-10 was well tolerated, with clinically relevant efficacy seen in improvements in cystoscopic bleeding, hematuria, and urinary incontinence. The benefit-risk profile supports the further clinical development of LP-10 at a tacrolimus dose of 4 mg."

Journal • P2a data • Hematological Disorders • Inflammation • Urinary Incontinence • Urology