지엔티파마

Overview

Nelonemdaz is the first "multi-target" neuroprotection drug designed to reduce brain damage after stroke or cardiac arrest.
Pharmacological action: (1) Inhibition of NMDA receptor subtype NR2B activity (2) Removal of free radicals (antioxidant)
Unlike non-selective NMDA receptor inhibitors, nelonemdaz is a proven safe drug that does not cause adverse drug effects such as psychoses in normal people and stroke patients.
Verification of safety and efficacy in the phase II clinical study (SONIC) in South Korea with 208 stroke patients undergoing a standard surgery to remove a blood clot.
Verification of safety and efficacy in the phase II clinical study (ENIS) in China with 238 stroke patients receiving thrombolytics.
Based upon the first interim analysis with 227 stroke patients of the phase III clinical study (ENIS III) in China, the IDMC (Independent data monitoring committee) recommended the continuation of the trial.
Due to the long-lasting COVID-19 pandemic in China, ENIS-3 was terminated early in January 2024.
In the Korean Phase III clinical trial (RODIN) involving 496 stroke patients who underwent thrombectomy within 12 hours of stroke onset, significant results were obtained in the group administered Nelonemdaz within 60 minutes of arrival at the emergency room.

Indications

Comparison Safety and Efficacy of Nelonemdaz and clinical trial drugs for stroke

	Type of stroke	Nelonemdaz	NMDA antagonists	Antioxidants
Treatment Time Window in vivo	Severe tMCAO	8 hour	Less than 1 hour	2-4 hour
	Mild tMCAO	48 hour	ND (Not Determined)
	Permanent MCAO	4 hour
	Forebrain ischemia	24 hour
Safety in human	Phase I for Healthy Subjects Phase II for Stroke	*Safe up to 6,000mg(IV)	SAE at target doses	SAE at target doses (e.g. edaravone)
Safety in human	Phase I for Healthy Subjects Phase II for Stroke	Two Phase I Studies 165 subjects in US & China Two Phase II Studies 447 patients in China & SK	SAE at target doses	SAE at target doses (e.g. edaravone)
Efficacy in human	Ischemic Stroke alone	ND	All failed	All failed except edaravone approval in Japan
	Ischemic stroke with thrombolytics	A phase III clinical study (ENIS III) was planned for 948 patients in China; IDMC (Jul 2022) recommended the continuation of the trial based upon interim analysis with 227 patients.		ND
	Ischemic stroke with thrombolytics	Due to COVID-19 pandemic, ENIS III was terminated (Jan 2024)		ND
	Ischemic stroke with endovascular thrombectomy	Promising beneficial effects in PII SOINC (N=209)	Nerinetide little beneficial effects in PIII (N=1105)	ND
	Ischemic stroke with endovascular thrombectomy	Significant results were obtained from stroke patients who received the drug within 60 minutes of arriving at the emergency room	Nerinetide little beneficial effects in PIII (N=1105)	ND
	Cardiac Arrest with ROSC	AWAKE trial was completed; Nelonemdaz reduced disability and death	ND	ND

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