ropivacaine liposomal (TLC590) / Taiwan Liposome Company - LARVOL DELTA

A Study on TLC590 for Managing Postsurgical Pain (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Taiwan Liposome Company | Not yet recruiting ➔ Recruiting

Enrollment open • Pain

Phase 2 Pharmacokinetics Study of TLC590 for Postsurgical Pain Management in Multiple Surgical Models (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Taiwan Liposome Company

New P2 trial • Pain

Phase 2/3 Study of TLC590 for Postsurgical Pain Management (clinicaltrials.gov) - P2/3 | N=415 | Not yet recruiting | Sponsor: Taiwan Liposome Company | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Gastroenterology • Pain

Phase 2/3 Study of TLC590 for Postsurgical Pain Management (clinicaltrials.gov) - P2/3 | N=415 | Not yet recruiting | Sponsor: Taiwan Liposome Company | Trial completion date: Dec 2023 ➔ Dec 2024 | Initiation date: Jan 2022 ➔ Feb 2023 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial initiation date • Trial primary completion date • Gastroenterology • Pain

Phase 2/3 Study to Evaluate the Safety and Efficacy of TLC590 for Postsurgical Pain Management (clinicaltrials.gov) - P2/3; N=400; Not yet recruiting; Sponsor: Taiwan Liposome Company

Clinical • New P2/3 trial • Gastroenterology • Pain

TLC Reports First Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Continuous excellent progress in EXCELLENCE, the Phase III pivotal clinical trial of TLC599 in ~500 patients with symptomatic knee osteoarthritis. Over 440 patients have reached the 24-week timepoint...There has been no safety concerns or serious adverse events related to treatment...The United States Food and Drug Administration (FDA) has scheduled an End-of-Phase 2 meeting with TLC in June to discuss the development plan for TLC590. With the meeting, TLC hopes to obtain FDA’s input and reach an agreement on the design parameters of the proposed pivotal clinical studies that will be used to support the TLC590 NDA application."

FDA event • Trial status • CNS Disorders • Osteoarthritis • Pain

TLC Reports Fiscal Year End 2020 Financial Results and Provides Business Update (GlobeNewswire) - "...the completion of patient enrollment, 504 patients have received their first injection of TLC599, dexamethasone sodium phosphate or normal saline in EXCELLENCE, the Phase III pivotal clinical trial of TLC599 for symptomatic knee osteoarthritis...planned End-of-Phase-2 meetings to occur in 2021 with the United States Food and Drug Administration (FDA) on the design of the clinical trials and production preparations."

Enrollment closed • FDA event • CNS Disorders • Osteoarthritis • Pain

TLC Announces Completion of US$15 Million Financing for Subsidiary InspirMed Inc. (GlobeNewswire) - "TLC...announced today that its subsidiary, InspirMed Inc., has completed a round of financing, raising US$15 million in cash from strategic investors in exchange for subsidiary equity...to maintain focus on its current pipeline of liposomal injectable formulation programs, such as TLC599 for osteoarthritis pain and TLC590 for postsurgical pain, while instilling to InspirMed funding designated for use in the development of inhalable drugs."

Financing • CNS Disorders • Osteoarthritis • Pain

TLC Provides Corporate Update at Investor Conference (GlobeNewswire) - "Patient enrollment of EXCELLENCE, the Phase III pivotal study of TLC599 for symptomatic knee osteoarthritis, is at 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020...Topline data of TLC’s leading program is expected in the second half of 2021. Preparations for pivotal studies of TLC590 for postsurgical pain management are currently underway....TLC is arranging discussions with the United States Food and Drug Administration (FDA) regarding the design of the pivotal clinical trials. In addition, TLC is preparing for scale-up production of TLC590...and New Drug Application submission must be the same as future commercial batches."

Enrollment status • New trial • P3 data: top line • CNS Disorders • Osteoarthritis • Pain

TLC to Present at Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit (GlobeNewswire) - "TLC...today announced that President Mr. George Yeh and Chief Medical Officer Dr. George Spencer-Green, MD, will be presenting at Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit on Wednesday, September 23, 2020 at 9:10am ET. The 40-minute live presentation will include...analyses of data on TLC’s pain programs – TLC599 and TLC590 – by Dr. Spencer-Green. During the virtual conference, which takes place September 21-23, 2020, TLC will also be participating in one-on-one sessions."

Live event • CNS Disorders • Osteoarthritis • Pain

TLC to Present at Cantor Virtual Global Healthcare Conference (GlobeNewswire) - "TLC...today announced that George Yeh, President of TLC, will be discussing recent activities regarding the company in a fireside chat with Kristen Kluska, Research Analyst, at Cantor Virtual Global Healthcare Conference on Tuesday, September 15, 2020 at 10:00am ET. The 30-minute fireside chat will be a Q&A session in which Mr. Yeh will introduce TLC and talk about the company’s leading programs: TLC599 for sustained relief of osteoarthritis pain and TLC590 for sustained relief of postsurgical pain, and introduce TLC19 for prevention and treatment of COVID-19."

Live event • CNS Disorders • Osteoarthritis • Pain

TLC to Present at HC Wainwright & Co. 22nd Annual Global Investment Conference (GlobeNewswire) - "TLC...today announced that the Company’s President Mr. George Yeh and Chief Medical Officer Dr. George Spencer-Green, MD, will be presenting at HC Wainwright & Co’s 22nd Annual Global Investment Conference on Monday, September 14, 2020, at 10:00am ET. The 20-minute live presentation will include a company overview and update by Mr. Yeh, with analyses of data on TLC’s pain programs – TLC599 and TLC590 – by Dr. Spencer-Green."

Live event • CNS Disorders • Osteoarthritis • Pain

TLC announces topline results for TLC590 phase II trial for postsurgical pain management following bunionectomy (GlobeNewswire) - P2, N=150; NCT03838133; Sponsor: Taiwan Liposome Company; "TLC...today announced topline results from the TLC590 Phase II clinical trial, a randomized, double-blind, placebo- and comparator- controlled study of TLC590 in patients following bunionectomy. Results show that TLC590 demonstrated greater reductions in pain than both placebo and bupivacaine through 168 hours."

P2 data • CNS Disorders • Pain

TLC Announces Topline Results for TLC590 Phase II Trial for Postsurgical Pain Management following Bunionectomy (GlobeNewswire, Taiwan Liposome Company, Ltd.) - P2, N=150; NCT03838133; Sponsor: Taiwan Liposome Company; "TLC...today announced topline results from the TLC590 Phase II clinical trial, a randomized, double-blind, placebo- and comparator- controlled study of TLC590 in patients following bunionectomy. Results show that TLC590 demonstrated greater reductions in pain than both placebo and bupivacaine through 168 hours....TLC590 was well-tolerated, with a safety profile comparable to bupivacaine and placebo. Most adverse events were mild and unrelated to the treatment. There were no serious adverse events in the TLC590 group."

P2 data • Pain

A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy (clinicaltrials.gov) - P2; N=150; Completed; Sponsor: Taiwan Liposome Company; Active, not recruiting ➔ Completed

Clinical • Trial completion

TLC announces early completion of patient enrollment in TLC590 phase ii clinical trial following bunionectomy (GlobeNewswire) - "TLC...announced the earlier-than-scheduled completion of patient enrollment in Part 2 of the TLC590 Phase II clinical trial, which is taking place across four sites in the United States. The randomized, double-blind, comparator- and placebo-controlled study will evaluate the analgesic efficacy and safety of TLC590 for postsurgical pain management in patients following bunionectomy. Topline data is expected to be reported in mid-2020."

Enrollment status • P2 data

TLC reports fiscal year end 2019 financial results and provides business update (GlobeNewswire) - "Commencement of patient enrollment in EXCELLENCE trial evaluating single and repeated administrations of TLC599 for knee osteoarthritis pain...Patient enrollment is expected to take about one year, and all patients will be followed for 52 weeks...Commencement of patient dosing in Part 2 of Phase II trial evaluating the analgesic efficacy of TLC590 following bunionectomy. With the first batch of patients dosed in January 2020, a total of about 150 patients will receive TLC590, bupivacaine or normal saline placebo at a ratio of 1:1:1 at the end of their bunion removal surgery."

Enrollment status • Trial status