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Also known as: Daridorexant, 1505484-82-1, Act-541468, Quviviq, Daridorexant [usan], Lmq24g57e9
Molecular Formula
C23H23ClN6O2
Molecular Weight
450.9  g/mol
InChI Key
NBGABHGMJVIVBW-QHCPKHFHSA-N
FDA UNII
LMQ24G57E9

Daridorexant
Nemorexant is under investigation in clinical trial NCT03101189 (A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects).
Daridorexant is an Orexin Receptor Antagonist. The mechanism of action of daridorexant is as an Orexin Receptor Antagonist.
1 2D Structure

Daridorexant

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(2S)-2-(5-chloro-4-methyl-1H-benzimidazol-2-yl)-2-methylpyrrolidin-1-yl]-[5-methoxy-2-(triazol-2-yl)phenyl]methanone
2.1.2 InChI
InChI=1S/C23H23ClN6O2/c1-14-17(24)6-7-18-20(14)28-22(27-18)23(2)9-4-12-29(23)21(31)16-13-15(32-3)5-8-19(16)30-25-10-11-26-30/h5-8,10-11,13H,4,9,12H2,1-3H3,(H,27,28)/t23-/m0/s1
2.1.3 InChI Key
NBGABHGMJVIVBW-QHCPKHFHSA-N
2.1.4 Canonical SMILES
CC1=C(C=CC2=C1N=C(N2)C3(CCCN3C(=O)C4=C(C=CC(=C4)OC)N5N=CC=N5)C)Cl
2.1.5 Isomeric SMILES
CC1=C(C=CC2=C1N=C(N2)[C@@]3(CCCN3C(=O)C4=C(C=CC(=C4)OC)N5N=CC=N5)C)Cl
2.2 Other Identifiers
2.2.1 UNII
LMQ24G57E9
2.3 Synonyms
2.3.1 MeSH Synonyms

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)-

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2015-06-22
3 Chemical and Physical Properties
Molecular Weight 450.9 g/mol
Molecular Formula C23H23ClN6O2
XLogP34.1
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count4
Exact Mass450.1571017 g/mol
Monoisotopic Mass450.1571017 g/mol
Topological Polar Surface Area88.9 Ų
Heavy Atom Count32
Formal Charge0
Complexity693
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

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.


5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Active Moiety
DARIDOREXANT
5.1.2 FDA UNII
LMQ24G57E9
5.1.3 Pharmacological Classes
Orexin Receptor Antagonists [MoA]; Orexin Receptor Antagonist [EPC]
5.2 ATC Code

N05


API SUPPLIERS

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Inke S.A

Spain

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FARMAK, a.s

Czech Republic

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Virtual BoothFarmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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Metrochem API Private Limited

India

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Moehs Iberica

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Supriya Lifescience

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MSN Laboratories

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Maithri Drugs

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Inke S.A

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Daridorexant

About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...

Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation.
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Daridorexant

About the Company : Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingr...

Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingredients (APIs), intermediates and specialized chemicals. The company primarily focuses on exporting its products, with the main markets being the EU, USA, India, Japan and Latin America. Additionally, Farmak offers contract manufacturing and custom synthesis services through its R&D department to support the clients.
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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Daridorexant

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Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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Daridorexant

About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...

Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 years, MOEHS has considerable technical experience in the production of these substances. At Moehs Group we have a large tradition and experience in the area of manufacturing of active pharmaceutical and veterinary ingredients, agrochemicals, nutraceutical, cosmetic, as well as fine chemistry in general, with high levels of quality and safety standards-GMP´s, ICH, approved by the FDA and TGA.
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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Daridorexant

About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...

Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Supriya follows industry standards and constantly improves to deliver quality products. Its facility is 47,000 square meters with dedicated areas for warehouse, QA, QC, R&D, production and finished products. The current capacity is 550 KL, with plans to expand to over 1000 KL by 2024. Supriya has 14 active USDMFs, 8 active CEPs, strong R&D and compliant facilities worldwide. Supriya works with innovators, generic companies, and as a CMO.
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About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products...

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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[{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708281000,"product":"DARIDOREXANT HYDROCHLORIDE","address":"PLOT NO.C-24, MNS HOUSE,","city":"HYDERABAD, AP.","supplier":"MAITHRI DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"TIANJIN","customer":"GREENPINE PHARMA GROUP ","customerCountry":"CHINA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"45000","totalValueFC":"22254.3","currency":"USD","unitRateINR":3693044,"date":"19-Feb-2024","totalValueINR":"1846522","totalValueInUsd":"22254.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"7650054","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.C-24, MNS HOUSE,, HYDERABAD, AP.","customerAddress":""}]
19-Feb-2024
19-Feb-2024
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Dosage Form : Tablet

Dosage Strength : 25MG

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Regulatory Info :

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Daridorexant

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Dosage Strength : 50MG

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Registration Country : India

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NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2024/12/05/2991987/0/en/Nxera-Pharma-Enrolls-First-Insomnia-Patient-in-its-Phase-3-Clinical-Trial-of-Daridorexant-in-South-Korea.html

GLOBENEWSWIRE
04 Dec 2024

https://www.globenewswire.com/news-release/2024/09/24/2951862/0/en/Nxera-Pharma-Receives-Approval-of-QUVIVIQ-daridorexant-25-and-50-mg-in-Japan-for-the-Treatment-of-Insomnia.html

GLOBENEWSWIRE
23 Sep 2024

https://www.globenewswire.com/news-release/2024/06/03/2891892/0/en/New-data-with-daridorexant-to-be-presented-at-SLEEP-2024.html

GLOBENEWSWIRE
03 Jun 2024

https://www.globenewswire.com//news-release/2023/10/31/2769844/0/en/Sosei-Heptares-Announces-Submission-of-New-Drug-Application-in-Japan-for-Daridorexant-ACT-541468-a-Dual-Orexin-Receptor-Antagonist-for-the-Treatment-of-Insomnia.html

GLOBENEWSWIRE
31 Oct 2023

https://www.prnewswire.com/news-releases/idorsia-announces-its-insomnia-medication-quviviq-daridorexant-is-now-covered-by-cvs-301872158.html

PR NEWSWIRE
10 Jul 2023

https://www.globenewswire.com/news-release/2023/06/12/2685940/0/en/Idorsia-launches-QUVIVIQ-daridorexant-in-Switzerland-a-first-in-class-treatment-for-chronic-insomnia-disorder-to-improve-both-nighttime-symptoms-and-daytime-functioning.html

GLOBENEWSWIRE
12 Jun 2023

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Company :

Daridorexant HCl

Drug Cost (USD) : 2,396,493

Year : 2022

Prescribers : 2862

Prescriptions : 4965

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ABOUT THIS PAGE

Daridorexant Manufacturers

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.

Daridorexant Suppliers

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.

Daridorexant GMP

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.

Daridorexant CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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