S-cibenzoline (CT-G20) / Celltrion - LARVOL DELTA

Celltrion, expanding the chemical field, develops NASH treatment ’Future’ [Google translation] (Health Korea News) - "...the company discontinued the phase 1b clinical trial of CT-G20, a new drug candidate for the treatment of hypertrophic cardiomyopathy (HCM). This is because the termination criteria of the protocol was met during dose escalation early in the process of dose escalation. In fact, as it corresponds to the early termination of clinical trials, it is expected that it will enter phase 2 clinical trials in the near future."

Trial termination • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P1 | N=23 | Terminated | Sponsor: Celltrion | Recruiting ➔ Terminated; The termination criteria of the protocol was met during dose escalation

Trial termination • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Celltrion | Trial completion date: Apr 2022 ➔ Sep 2022 | Trial primary completion date: Apr 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Celltrion | Trial completion date: Jan 2022 ➔ Apr 2022 | Trial primary completion date: Jan 2022 ➔ Apr 2022

Trial completion date • Trial primary completion date • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy

Celltrion's first chemical drug 'CT-G20' outlines revealed [Google translation] (Health Korea News) - "According to the Korean Intellectual Property Office, Celltrion applied for a patent for the invention of a 'pharmaceutical composition for the treatment of hypertrophic cardiomyopathy and a treatment method using the composition', and the registration process is currently underway. The patent application was filed in April, and the specification was recently published according to the registration procedure."

Patent • Cardiomyopathy • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Celltrion; Trial completion date: Jun 2021 ➔ Jan 2022; Trial primary completion date: Jun 2021 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Obstructive Hypertrophic Cardiomyopathy

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Celltrion; Trial completion date: Dec 2020 ➔ Jun 2021; Trial primary completion date: Dec 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Cardiomyopathy • Cardiovascular

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants (clinicaltrials.gov) - P1; N=72; Completed; Sponsor: Celltrion; Recruiting ➔ Completed

Clinical • Trial completion

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Celltrion

Clinical • New P1 trial • Cardiomyopathy • Cardiovascular

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: Celltrion; N=48 ➔ 72; Trial completion date: Jun 2019 ➔ May 2020; Trial primary completion date: Jun 2019 ➔ May 2020

Clinical • Enrollment change • Trial completion date • Trial primary completion date