---
schema_version: "secwatch.filing_event.v1"
accession: "0001753926-25-000211"
form_type: "8-K"
ticker: "LIPO"
cik: "0001347242"
company_name: "LIPELLA PHARMACEUTICALS INC."
filed_at: "2025-02-11T23:59:59+00:00"
generated_at: "2026-05-26T23:17:36.955610+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Lipella reports positive Phase 2a results for LP-310 in oral lichen planus; FDA okays expanded access

## Summary
- FDA approved Expanded Access Program for LP-310 (oral rinse for OLP) on Feb 6, 2025.
- Phase 2a topline: statistically significant improvements in pain (NRS), IGA, REU, and OLPSSM at weeks 1, 4, 6.
- No product-related SAEs, no dropouts; tacrolimus blood levels undetectable or minimal in all patients.
- Trial advancing to 0.5 mg dose cohort; recruitment to conclude first half 2025.
- Company plans Phase 2b IND submission and Breakthrough Therapy request in second half 2025.

## SEC filing metadata
- accession: 0001753926-25-000211
- form_type: 8-K
- ticker: LIPO
- cik: 0001347242
- company_name: LIPELLA PHARMACEUTICALS INC.
- filed_at: 2025-02-11T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347242/000175392625000211/0001753926-25-000211-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347242/000175392625000211/g084697_8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001753926-25-000211
- JSON: https://secwatch.observer/filing/0001753926-25-000211.json
- Plain text: https://secwatch.observer/filing/0001753926-25-000211.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.