Drug Profile

Levosimendan - AbbVie/Tenax Therapeutics

Alternative Names: Daxim; ODM 109; OR-1259; Simdax; TNX-101; TNX-102 - Tenax Therapeutics; TNX-103; TNX102

Latest Information Update: 18 Mar 2025

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At a glance

Originator Orion
Developer Abbott Laboratories; AbbVie; Imperial College of Science, Technology and Medicine; Orion; Tenax Therapeutics; Yooyoung Pharmaceutical
Class Antiarrhythmics; Cardiotonics; Cardiovascular therapies; Hydrazones; Nitriles; Pyridazines; Small molecules; Vasodilators
Mechanism of Action Calcium binding protein modulators; Calcium-sensitising phosphodiesterase inhibitors; Potassium channel agonists; Type 3 cyclic nucleotide phosphodiesterase inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Amyotrophic lateral sclerosis
New Molecular Entity Yes

Marketed Acute heart failure
Phase III Amyotrophic lateral sclerosis; Chronic heart failure; Low cardiac output; Pulmonary hypertension
Discontinued Myocardial infarction; Septic shock; Stroke; Transient ischaemic attacks

05 Mar 2025 US FDA completes review of updated Phase III development plan for TNX 103
05 Mar 2025 Efficacy and adverse events data from a phase III LEVEL trial in Pulmonary hypertension released by Tenax Therapeutics
05 Mar 2025 Tenax Therapeutics plans a phase III LEVEL 2 trial for Pulmonary hypertension in 2025

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