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Details:
Quviviq (daridorexant) is a dual orexin receptor antagonist (DORA) acting on both orexin 1 and orexin 2 receptors equipotently, approved for the management of adult patients with insomnia.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Quviviq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2023
Details:
Quviviq (daridorexant) is a dual orexin receptor antagonist (DORA) acting on both orexin 1 and orexin 2 receptors equipotently, it is being developed for the management of adult patients with insomnia.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Quviviq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2023
Details:
Quviviq (daridorexant) is a dual orexin receptor antagonist (DORA) that was approved in 2022 in the United States and the European Union, and it is the only FDA-approved insomnia medication being evaluated in this study.
Lead Product(s): Daridorexant
Therapeutic Area: Psychiatry/Psychology Product Name: Quviviq
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2023
Details:
Quviviq™ (daridorexant) is a dual orexin receptor antagonist (DORA) acting on both orexin 1 and orexin 2 receptors equipotently, it is being developed for the management of adult patients with insomnia.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Quviviq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2023
Details:
The improvement in sleep onset, sleep maintenance and daytime functioning seen with 50 mg daridorexant were sustained for up to 12 months. Importantly, long-term treatment with daridorexant was not associated with any tolerance or physical dependence.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Quviviq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2022
Details:
QUVIVIQ (daridorexant) will be the first dual orexin receptor antagonist (DORA) available in Switzerland for the treatment of chronic insomnia disorder. QUVIVIQ reduces nocturnal hyperarousal to improve sleep (onset and maintenance) without nextmorning residual effects.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Quviviq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2022
Details:
Under the agreement, Simcere will be granted an exclusive right to develop and commercialize daridorexant (ACT-541468) in the Greater China region (Mainland China, Hong Kong, and Macau), one of the world's largest pharmaceutical markets.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: ACT-541468
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jiangsu Simcere Pharmaceutical
Deal Size: $50.0 million Upfront Cash: $30.0 million
Deal Type: Licensing Agreement November 16, 2022
Details:
QUVIVIQ (daridorexant), is the first dual orexin receptor antagonist (DORA) to be available to patients in Italy and Germany for the treatment of chronic insomnia disorder.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Quviviq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2022
Details:
The study met both primary and secondary efficacy endpoint measures ACT-541468 (Daridorexant) significantly improved sTST from baseline compared to placebo at 28 days (p<0.001 for 50 mg, p=0.042 for 25 mg).
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: ACT-541468
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mochida Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2022
Details:
QUVIVIQ (daridorexant) was approved by the Food and Drug Administration in early January for adults who have trouble falling or staying asleep (insomnia). The product was first commercially available on May 2, through the pharmacy services provider.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Quviviq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership May 13, 2022
Details:
Idorsia receives a positive opinion from the Committee for Medicinal Products for Human Use for QUVIVIQ™ (daridorexant) for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Quviviq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2022
Details:
Idorsia to capitalize upon the unique opportunity to transform the insomnia treatment paradigm, notably in Europe where daridorexant would be the first dual orexin receptor antagonist made available to patients with insomnia.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Quviviq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Idorsia Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 26, 2022
Details:
The approval of QUVIVIQ (Daridorexant), a dual orexin receptor antagonist is based on, Phase 3 clinical program that demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance, as well as patient-reported total sleep time.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Quviviq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2022
Details:
The placebo-controlled studies investigated the effects of three doses of daridorexant (10 mg, 25 mg, and 50 mg) on sleep and daytime functioning parameters, objectively in a sleep lab by polysomnography and subjectively with a daily patient diary at home.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: ACT-541468
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2021
Details:
The increased liquidity will be used to prepare for the launch of daridorexant and further fund Idorsia’s diversified pipeline.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $592.3 million Upfront Cash: Undisclosed
Deal Type: Financing October 21, 2020
Details:
The proceeds from the offering will be used to support the regulatory filing and, if approved, commercial launch of daridorexant and to fund the further development of its diversified pipeline.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $632.0 million Upfront Cash: Undisclosed
Deal Type: Financing October 08, 2020
Details:
The strategic collaboration brings Idorsia’s lead investigational compound, daridorexant, and expertise in the science of the orexin system, together with Syneos Health’s robust customer-facing sales expertise and proven track record in launching new products in the US.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Syneos Health
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 31, 2020
Details:
Results from the first pivotal Phase 3 study investigating 25 and 50 mg doses of its dual orexin receptor antagonist, daridorexant, in adult and elderly patients with insomnia, are to be presented at SLEEP 2020.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: ACT-541468
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 13, 2020
Details:
Treatment with daridorexant in 47 adult patients (ranging from 16 to 64 years) showed a significant dose-dependent decrease in WASO at Day 1 & 2 (average decrease of wake time after sleep onset from baseline on the 2 nights of treatment.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
The study confirms the findings of the first pivotal study, demonstrating efficacy of treatment with daridorexant on objective and subjective sleep parameters and showed positive effects on daytime functioning, with patients reporting no morning sleepiness and other symptoms.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: ACT-541468
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
The study demonstrated efficacy of treatment with daridorexant on objective and subjective sleep parameters and daytime performance with no residual effect in the morning.
Lead Product(s): Daridorexant
Therapeutic Area: Sleep Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2020
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