Initiator Pharma A/S, a clinical-stage biotech company, today announced that the World Health Organization (WHO) has selected the International Nonproprietary Name (INN) pudafensine as the official generic name for the company's patented candidate drug IP2015, which is in clinical development in erectile dysfunction and neuropathic pain.
”We are pleased that our generic name application now is accepted and approved by the WHO. That we are now able to use the generic name for our drug candidate is a clear validation of the project and an important step on the way to a product. From now on, we will use pudafensine in all communication regarding the drug candidate,” says Claus Elsborg Olesen, CEO at Initiator Pharma.
Pudafensine (formerly IP2015 (7-[(Exo-8-azabicyclo[3.2.1]octan-3-yl)oxy]-3-methoxy-chromen-2-one)), Initiator Pharma's most advanced candidate drug, is in clinical development for both organic erectile dysfunction and neuropathic pain. Within the indication erectile dysfunction, a multi-center phase IIb study is currently being conducted together with MAC Clinical Research in 120 otherwise healthy organic Erectile dysfunction patients. Dosing of all patients in the phase IIb study is expected to be completed in the first half of 2023.
A recently developed solid dosage form of pudafensine is undergoing a Phase I pharmacokinetic study in healthy subjects, this will enable bridging of all previous data sets to all future clinical studies on pudafensine.