English name: Daridorexant
CAS: 1505484-82-1, 1792993-84-0 (HCl)(API)
Code name: ACT541468
English Trade Name: Quviviq
R&D Company: Idorsia Pharmaceuticals; Centrum Pharmaceuticals
Indication: Insomnia
FDA approval: January 7, 2022
EMA approval: April 29, 2022
On December 5, 2019, Idorsia and Mochida announced that they have entered into an exclusive license agreement for the supply, co-development and co-marketing of daridorexant in Japan for the treatment of insomnia and related disorders.Idorsia will receive an initial payment of 1 billion yen (approximately CHF 9 million) and will be entitled to three additional development and regulatory milestones.Idorsia will also receive sales milestones and tiered royalties based on net sales achieved by Mochida. Costs associated with the co-development of daridorexant will be shared by both parties. With respect to future development programs, Idorsia will be responsible for the design and implementation of additional preclinical and clinical studies, as well as for registration with health authorities under the supervision of the Joint Development Committee. In the event that Idorsia wishes to transfer the license for daridorexant for use in any field other than insomnia and related disorders to a third party in Japan, Mochida will be granted a right of first refusal.
In November 2022, Centrum Pharmaceuticals announced that the Group entered into an exclusive license agreement with Idorsia Pharmaceuticals Ltd.(Idorsia) on November 15, 2022 for Daridorexant, an insomnia drug. Under the agreement, the Group will be granted exclusive rights to develop and commercialize the product in the Greater China region.Idorsia will receive an initial payment of US$30 million and will be eligible to receive additional milestone payments of US$20 million upon receipt of regulatory approvals from the National Medicines and Pharmaceutical Administration (NMPA), as well as commercialization milestone payments and low double-digit percentage tiers based on future sales. royalties based on future sales.
On July 20, 2023, Centaurus Pharmaceuticals announced that Daridorexant Hydrochloride Tablets, a novel anti-insomnia drug developed by the enterprise in collaboration with Idorsia, has received a Notice of Approval of Drug Clinical Trial issued by the State Drug Administration (SDA) for the treatment of adult patients with insomnia whose symptoms have persisted for at least 3 months and are having an impact on daytime function.
On July 20, 2023, Idorsia announced the completion of a transaction with Sosei Heptares for Idorsia's Asia Pacific (excluding China) business. The transaction included the transfer of the 2009 PIVLAZ license and the co-acquisition of an exclusive license for daridorexant in the region.
