Initiator Pharma’s IP2015 obtains the International Nonproprietary Name pudafensine
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Beskrivning
| Land | Danmark |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
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.
For additional information about Initiator Pharma, please contact:
Claus Elsborg Olesen, CEO
Telephone: +45 6126 0035
E-mail: ceo@initiatorpharma.com
About Initiator Pharma
Initiator Pharma A/S is a Danish clinical stage life science company developing innovative drugs that target key unmet medical needs within the central and peripheral nervous system. Initiator Pharma’s pipeline consists of two clinical stage assets – IP2015 and IP2018 – and two preclinical assets. The company is currently conducting a Phase 2b trial with IP2015 in erectile dysfunction of organic origin, and successfully completed a Phase 1 proof of principle trial in neuropathic pain in 2022. With IP2018 the company is conducting a Phase 2a trial for the treatment of erectile dysfunction of psychogenic origin.
Initiator Pharma is listed on Nasdaq First North Growth Market (ticker: INIT). Redeye AB is the company’s Certified Adviser. For more information, please visit www.initiatorpharma.com.