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A Study on TLC590 for Managing Postsurgical Pain

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 2, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Taiwan Liposome Company to TLC Biopharmaceuticals, Inc.
    • Site contacts updated at 2 of 2 sites
    v4
  2. Start date changed from estimate of Oct 2024 to Sep 30, 2024v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2024 to Oct 2024
    • Site details revised at 2 of 2 sites
    • Study title shortened, about 6 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This Phase 2 open-label trial investigates the pharmacokinetics (PK), pharmacodynamics, and safety profile of TLC590 across various surgical procedures. Researchers aim to determine the maximum tolerated dose (MTD) of TLC590 via Safety Monitoring Committee (SMC). The study evaluates TLC590 in bunionectomy, laparoscopy-assisted open ventral hernia repair, breast augmentation, abdominoplasty, and total knee arthroplasty models. Additionally, it determines the relative bioavailability of TLC590 to ropivacaine injection.
Trial Details
NCT Number NCT06574269
Lead Sponsor TLC Biopharmaceuticals, Inc.
Conditions
(from sponsor)		 Postsurgical Pain Management
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov