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Takeda Halts Phase II Studies For Key R&D Asset TAK-994 In Narcolepsy

‘Wave 1’ Drug Part Of Orexin Agonist Portfolio

 
• By Mandy Jackson

The company stopped Phase II clinical trials for TAK-994 to assess a safety signal and determine next steps for the drug, which is viewed as a key product in Takeda’s push for blockbuster revenue growth. 

Waves crashing against the shoreline at sunset along the Western coast of Oahu
Takeda's TAK-994 could be its first Wave 1 R&D program to crash • Source: Alamy

Takeda Pharmaceutical Co. Ltd.’s plan to increase annual revenue to JPY5,000bn ($48bn) by fiscal year 2030 hit a roadblock on 5 October when the company said it stopped two mid-stage clinical trials for its narcolepsy drug candidate TAK-994 due to a safety signal observed in the studies. The oral therapy is part of a portfolio of orexin agonists that Takeda forecast to generate up to $6bn in revenue across narcolepsy types 1 and 2 and idiopathic hypersomnia.

The Japanese big pharma did not outline the type of safety signal it saw in the placebo-controlled Phase II trials – one enrolling 112 patients with narcolepsy type 1 (NT1) and another meant to enroll 202 people with NT1 and NT2 with primary completion dates in January and April 2022, respectively, according to clinicaltrials.gov

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