Pharmazz has entered into a license agreement with Dr Reddy’s Laboratories to commercialise Centhaquine in India. Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).
As per the agreement, Dr Reddy’s has received exclusive rights to market and distribute Centhaquine in India. Pharmazz will be entitled to upfront payments and royalties. Dr Reddy’s will market the product under the brand name Lyfaquin, which it shall own. In addition to India, Dr Reddy’s also receives marketing rights for Lyfaquin from Pharmazz for Nepal.
Centhaquine is a frontline therapy used along with the standard of care and is well-positioned to a critical unmet need as a pharmacologically active resuscitative agent. A decrease in the volume of blood circulation from blood or fluid loss due to trauma, gastrointestinal bleeding, major surgery, postpartum hemorrhage, diarrhea, or vomiting can cause hypovolemic shock. About 1.9 million people worldwide die because of hemorrhagic shock every year, most dying within the first 6 hours. Centhaquine activates venous alpha2B adrenergic receptors to increase cardiac preload and activates central alpha2A adrenergic receptors to decrease cardiac afterload. Thereby, centhaquine converts the venous unstressed blood volume to stressed blood volume and improves cardiac output and blood circulation, making it an ideal candidate for the resuscitation of patients with hypovolemic shock.
Centhaquine was approved in India by Drugs Controller General of India following a successful Ph III clinical trial there, the results of which are published in a manuscript titled “A Multicentric, Randomized, Controlled Ph III Study of Centhaquine (Lyfaquin, as a Resuscitative Agent in Hypovolemic Shock Patients.” The manuscript is published in DRUGS and is available at: https://link.springer.com/article/10.1000/s40265-021-01547-5
Pharmazz received permission from the US Food and Drug Administration (FDA) to conduct a Phase III clinical trial of centhaquine in hypovolemic shock patients. It assesses the safety and efficacy of centhaquine in patients with hypovolemic shock. The Phase III randomised double-blind, placebo-controlled study will be conducted in 430 patients where patients will receive either an intravenous infusion of 0.01 mg/Kg of centhaquine or a placebo. All patients will receive the standard of care. A 28-day all-cause mortality is the primary endpoint.
The Phase III clinical trial is registered at clinicaltrials.gov (NCT05251181), providing details of the trial design and all the endpoints.