Centhaquine Set to Enter US-FDA Approved Phase 3 Clinical Trial in US and Europe: First Ever Indian Drug to get Direct Approval for such a Trial
Pharmazz India Private Limited, a majority-owned subsidiary of Pharmazz, Inc.’s first-in-class drug developed in India, Centhaquine has become the first-ever Indian drug to get direct approval from the US-FDA to enter phase 3 clinical trials in the United States and the European Union. Pharmazz, Inc. a Delaware Corporation based in Illinois, USA is an innovative biopharmaceutical company with two approved products, a promising drug pipeline, and a seasoned management team. It is focused on discovering, acquiring, developing, and commercializing therapeutics that target critical care medicine.
Pharmazz India Private Limited obtained marketing authorization for Lyfaquin® (INN: Centhaquine) to manage hypovolemic shock in India in May 2020. Centhaquine citrate, a resuscitative agent for managing hypovolemic shock, was found to be effective without causing arterial constriction or an increase in blood pressure by enhancing the output from the heart. It is a compound that acts via a unique mechanism of action. Since more than half of our blood is pooled on the venous side of circulation and is not supplying oxygen and nutrition to the tissues, centhaquine can divert that blood to the heart and on the arterial side of circulation to increase tissue blood perfusion and increase the supply of oxygen and nutrition to the tissues and hence save organ from failure.
In clinical studies already conducted in India, Centhaquine has been found to be safe and effective in improving blood pressure and reducing mortality having been administered to approximately 6000 patients across 250+ hospitals throughout the country. An ongoing phase IV clinical study has enrolled 139 patients until now across many leading Indian hospitals.
Prof. Anil Gulati, Inventor, Chairman, and Chief Executive Officer at Pharmazz, Inc. has been the force behind leading the discovery, development, and launch of Lyfaquin. He leads clinical development and commercialization of first-in-class drug products in critical care medicine at Pharmazz, Inc. Commenting on this rare milestone, he said, “It is indeed a proud moment for us to have received direct approval for US-FDA approved phase 3 clinical trials in the United States and the European Union. Centhaquine was first synthesized in the early 1970s at the Central Drug Research Institute, Lucknow, India. However, it could not be developed as a drug. Decades later, one of my colleagues, Dr. Manish Lavhale, was given the task of conducting a series of experiments, and the findings were so promising that we decided to develop it as a drug for patients going in shock with circulatory failure.”
Explaining the condition further, Dr. Manish Lavhale, who is now the Managing Director of Pharmazz India, said, “Hypovolemic shock is a serious life-threatening medical condition with about 20% mortality rate. It results from excessive fluid loss leading to inadequate tissue perfusion and oxygenation. Immediate medical attention is required because any delay in therapy can lead to irreversible shock, multi-organ failure, and death. Hypovolemic shock can occur due to haemorrhagic causes (blood loss) or non-haemorrhagic causes (fluid loss). Massive loss of blood or fluids causes a lack of oxygen supply to the tissues leading to failure of multiple organs and death. Agents developed to resuscitate such patients have limited success because most of them improve blood pressure but also cause constriction of the arteries, hence the blood supply to the vital organ does not improve. In such a scenario, Centhaquine is a life saver and also extremely effective as a pre-emptive formulation.”
The compound has already received the Manufacturing and Marketing Authorisation by Indian Regulatory Agency, CDSCO in May 2020. The US FDA directly approved Pharmazz’s phase III IND application and the European Medicine Agency provided its Scientific Advice in November 2022 to assist in the development of Centhaquine for marketing in the European Union. With the successful completion of this trial, Centhaquine will become a first-in-class new chemical entity that originated from India to become a drug that is needed for unmet medical need to save lives across the globe. Centhaquine can of particular help in saving lives of patients with massive blood loss in civilian or military population