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1. ((s)-(2-(5-chloro-4-methyl-1h-benzo(d)imidazol-2-yl)-2-methylpyrrolidin-1-yl) (5 Methoxy-2-(2h-1,2,3-triazol-2-yl)phenyl)methanone)
2. Act-541468
3. Daridorexant
4. Methanone, ((2s)-2-(6-chloro-7-methyl-1h-benzimidazol-2-yl)-2-methyl-1-pyrrolidinyl)(5-methoxy-2-(2h-1,2,3-traizol-2-yl)phenyl)-
1. Daridorexant
2. 1505484-82-1
3. Act-541468
4. Quviviq
5. Daridorexant [usan]
6. Lmq24g57e9
7. Act541468
8. [(2~{s})-2-(6-chloranyl-7-methyl-1~{h}-benzimidazol-2-yl)-2-methyl-pyrrolidin-1-yl]-[5-methoxy-2-(1,2,3-triazol-2-yl)phenyl]methanone
9. [(2s)-2-(5-chloro-4-methyl-1h-benzimidazol-2-yl)-2-methylpyrrolidin-1-yl]-[5-methoxy-2-(triazol-2-yl)phenyl]methanone
10. [(2s)-2-(5-chloro-4-methyl-1h-benzimidazol-2-yl)-2-methylpyrrolidin-1-yl][5-methoxy-2-(2h-1,2,3-triazol-2-yl)phenyl]methanone
11. Methanone, ((2s)-2-(6-chloro-7-methyl-1h-benzimidazol-2-yl)-2-methyl-1-pyrrolidinyl)(5-methoxy-2-(2h-1,2,3-triazol-2-yl)phenyl)-
12. Nemorexant (former Name)
13. Daridorexant [inn]
14. Unii-lmq24g57e9
15. Daridorexant [who-dd]
16. Chembl4297590
17. Schembl16766318
18. Gtpl11648
19. Bdbm334973
20. Dtxsid701336356
21. Nemorexant; Act-541468
22. Who 10679
23. Us9732075, Example 5.36
24. At32805
25. Db15031
26. Hy-109095
27. Cs-0039396
28. Act 541468;act-541468
29. (2s)-2-(5-chloro-4-methyl-1h-benzimidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2h-1,2,3-triazol-2-yl)phenyl)methanone
30. (s)-(2-(5-chloro-4-methyl-1h-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5 Methoxy-2-(2h-1,2,3-triazol-2-yl)phenyl)methanone
31. (s)-2-(5-chloro-4-methyl-1h Benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-(2h-1,2,3-triazol-2-yl)phenyl)methanone
32. [(s)-2-(5-chloro-4-methyl-1h-benzoimidazol-2-yl)-2-methyl-pyrrolidin-1-yl]-(5-methoxy-2-[1,2,3]triazol-2-yl-phenyl)-methanone
Molecular Weight | 450.9 g/mol |
---|---|
Molecular Formula | C23H23ClN6O2 |
XLogP3 | 4.1 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 4 |
Exact Mass | 450.1571017 g/mol |
Monoisotopic Mass | 450.1571017 g/mol |
Topological Polar Surface Area | 88.9 Ų |
Heavy Atom Count | 32 |
Formal Charge | 0 |
Complexity | 693 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.
N05
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41227
Submission : 2025-01-20
Status : Active
Type : II
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Daridorexant is a Controlled Substance drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Sleep Initiation and Maintenance Disorders.
Lead Product(s): Daridorexant,Inapplicable
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 19, 2025
Lead Product(s) : Daridorexant,Inapplicable
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy & Safety of Daridorexant in Participants with Insomnia
Details : Daridorexant is a Controlled Substance drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Sleep Initiation and Maintenance Disorders.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
June 19, 2025
Details:
Undisclosed
Lead Product(s): Daridorexant,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Controlled Substance
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 22, 2024
Lead Product(s) : Daridorexant,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
March 22, 2024
Details:
Undisclosed
Lead Product(s): Daridorexant,Inapplicable
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Controlled Substance
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 24, 2023
Lead Product(s) : Daridorexant,Inapplicable
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Daridorexant in Chinese Patients With Insomnia Disorder
Details : Undisclosed
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
August 24, 2023
Details:
Undisclosed
Lead Product(s): Daridorexant,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Controlled Substance
Sponsor: U.S. Army Medical Research and Development Command | PPD | Berry Consultants | Idorsia Pharmaceuticals | Cambridge Cognition | Citeline
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 17, 2023
Lead Product(s) : Daridorexant,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : U.S. Army Medical Research and Development Command | PPD | Berry Consultants | Idorsia Pharmaceuticals | Cambridge Cognition | Citeline
Deal Size : Inapplicable
Deal Type : Inapplicable
Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
Details : Undisclosed
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
July 17, 2023
Details:
Undisclosed
Lead Product(s): Daridorexant,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Controlled Substance
Sponsor: Idorsia Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 29, 2023
Lead Product(s) : Daridorexant,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Idorsia Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
June 29, 2023
Details:
Undisclosed
Lead Product(s): Daridorexant,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Controlled Substance
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 26, 2023
Lead Product(s) : Daridorexant,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 ...
Details : Undisclosed
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
May 26, 2023
Details:
Undisclosed
Lead Product(s): Daridorexant,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Controlled Substance
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 27, 2023
Lead Product(s) : Daridorexant,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
January 27, 2023
Details:
Undisclosed
Lead Product(s): Daridorexant,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Controlled Substance
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 30, 2022
Lead Product(s) : Daridorexant,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women
Details : Undisclosed
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
November 30, 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,Inapplicable
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Jiangsu Simcere Pharmaceutical
Deal Size: $50.0 million Upfront Cash: $30.0 million
Deal Type: Licensing Agreement November 16, 2022
Lead Product(s) : Daridorexant,Inapplicable
Therapeutic Area : Sleep
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Jiangsu Simcere Pharmaceutical
Deal Size : $50.0 million
Deal Type : Licensing Agreement
Simcere and Idorsia Enter Into a Licensing Agreement for Daridorexant in China
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.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : $30.0 million
November 16, 2022
Details:
Undisclosed
Lead Product(s): Daridorexant,Inapplicable
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Controlled Substance
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 27, 2022
Lead Product(s) : Daridorexant,Inapplicable
Therapeutic Area : Sleep
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
October 27, 2022
6-CHLORO-2,3-DIAMINO TOLUENE HYDROCHLORIDE
CAS Number : 103146-25-4
End Use API : Daridorexant
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
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Global Sales Information
Company : Idorsia Pharmac
Daridorexant HCl
Drug Cost (USD) : 16,342,719
Year : 2023
Prescribers : 10838
Prescriptions : 30811
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Idorsia Pharmac
Daridorexant HCl
Drug Cost (USD) : 2,396,493
Year : 2022
Prescribers : 2862
Prescriptions : 4965
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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ABOUT THIS PAGE
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PharmaCompass offers a list of Daridorexant API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Daridorexant manufacturer or Daridorexant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Daridorexant manufacturer or Daridorexant supplier.
PharmaCompass also assists you with knowing the Daridorexant API Price utilized in the formulation of products. Daridorexant API Price is not always fixed or binding as the Daridorexant Price is obtained through a variety of data sources. The Daridorexant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Daridorexant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daridorexant, including repackagers and relabelers. The FDA regulates Daridorexant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daridorexant API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Daridorexant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Daridorexant supplier is an individual or a company that provides Daridorexant active pharmaceutical ingredient (API) or Daridorexant finished formulations upon request. The Daridorexant suppliers may include Daridorexant API manufacturers, exporters, distributors and traders.
click here to find a list of Daridorexant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Daridorexant DMF (Drug Master File) is a document detailing the whole manufacturing process of Daridorexant active pharmaceutical ingredient (API) in detail. Different forms of Daridorexant DMFs exist exist since differing nations have different regulations, such as Daridorexant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daridorexant DMF submitted to regulatory agencies in the US is known as a USDMF. Daridorexant USDMF includes data on Daridorexant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daridorexant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Daridorexant suppliers with USDMF on PharmaCompass.
Daridorexant Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Daridorexant GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Daridorexant GMP manufacturer or Daridorexant GMP API supplier for your needs.
A Daridorexant CoA (Certificate of Analysis) is a formal document that attests to Daridorexant's compliance with Daridorexant specifications and serves as a tool for batch-level quality control.
Daridorexant CoA mostly includes findings from lab analyses of a specific batch. For each Daridorexant CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Daridorexant may be tested according to a variety of international standards, such as European Pharmacopoeia (Daridorexant EP), Daridorexant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Daridorexant USP).