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Also known as: 1138245-21-2, Mirogabalin besilate, Mirogabalin besylate [usan], 01f4frp8yl, 2-[(1r,5s,6s)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic acid;benzenesulfonic acid, Mirogabalin besilate (jan)
Molecular Formula
C18H25NO5S
Molecular Weight
367.5  g/mol
InChI Key
OKJXJRVWXYRSAN-TXULWXBWSA-N
FDA UNII
01F4FRP8YL

Mirogabalin Besylate
1 2D Structure

Mirogabalin Besylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[(1R,5S,6S)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic acid;benzenesulfonic acid
2.1.2 InChI
InChI=1S/C12H19NO2.C6H6O3S/c1-2-8-3-9-5-12(7-13,6-11(14)15)10(9)4-8;7-10(8,9)6-4-2-1-3-5-6/h4,9-10H,2-3,5-7,13H2,1H3,(H,14,15);1-5H,(H,7,8,9)/t9-,10-,12-;/m1./s1
2.1.3 InChI Key
OKJXJRVWXYRSAN-TXULWXBWSA-N
2.1.4 Canonical SMILES
CCC1=CC2C(C1)CC2(CC(=O)O)CN.C1=CC=C(C=C1)S(=O)(=O)O
2.1.5 Isomeric SMILES
CCC1=C[C@@H]2[C@H](C1)C[C@@]2(CC(=O)O)CN.C1=CC=C(C=C1)S(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
01F4FRP8YL
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 1138245-21-2

2. Mirogabalin Besilate

3. Mirogabalin Besylate [usan]

4. 01f4frp8yl

5. 2-[(1r,5s,6s)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic Acid;benzenesulfonic Acid

6. Mirogabalin Besilate (jan)

7. Mirogabalin Besylate (usan)

8. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)acetic Acid Compound With Benzenesulfonic Acid (1:1)

9. Bicyclo(3.2.0)hept-3-ene-6-acetic Acid, 6-(aminomethyl)-3-ethyl-, (1r,5s,6s)-, Benzenesulfonate (1:1)

10. Mirogabalin Besilate [jan]

11. Unii-01f4frp8yl

12. Mirogabalin Besilate [who-dd]

13. Schembl1883872

14. Chembl3545257

15. Amy16760

16. Ex-a2817

17. Mfcd31631215

18. Ac-30336

19. Hy-108006

20. Cs-0027136

21. D10790

22. A901402

23. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)acetic Acid Besylate

24. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)aceticacidbesylate

25. ((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo(3.2.0)hept-3-en-6-yl)acetic Acid Monobenzenesulfonate

26. [(1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl]acetic Acid Benzenesulfonate;

2.4 Create Date
2014-10-20
3 Chemical and Physical Properties
Molecular Weight 367.5 g/mol
Molecular Formula C18H25NO5S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count6
Rotatable Bond Count5
Exact Mass367.14534407 g/mol
Monoisotopic Mass367.14534407 g/mol
Topological Polar Surface Area126 Ų
Heavy Atom Count25
Formal Charge0
Complexity494
Isotope Atom Count0
Defined Atom Stereocenter Count3
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

USDMF

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Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39342

Submission : 2023-12-29

Status : Active

Type : II

AMI Lifesciences

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Lee Pharma Ltd

India

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38908

Submission : 2023-09-20

Status : Active

Type : II

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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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Mirogabalin Besylate

About the Company :

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
Metrochem

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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Mirogabalin Besylate

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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Mirogabalin Besylate

About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...

Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
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Virtual BoothAptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

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Mirogabalin Besilate

About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...

Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to GMP standards. We take great pride in producing top-notch intermediates through our fully backward-integrated process. Aptra Synthesis Private Limited (ASPL) stands as one of the rapidly emerging manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi-finished Formulations), and Intermediates.
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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Mirogabalin Besylate

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing and supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US and the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Mirogabalin Besilate

About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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Lee Pharma

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Lee Pharma

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Mirogabalin Besylate

About the Company : Lee helps you focus on the business results that matter to your company. Over the years, we have leveraged our position in the global market with an enviable list of clients and a ...

Lee helps you focus on the business results that matter to your company. Over the years, we have leveraged our position in the global market with an enviable list of clients and a phenomenal growth rate achieved through product innovation, dedicated teams and timely implementation of solutions. Our success is based on providing a value-added service by adopting a customer-orientated approach. Our corporate independence allows us to respond as fast as possible, gives us a greater flexibility, and enables us to invest in plant and processes.
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Mirogabalin Besylate

About the Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Active Pharmaceutical Ing...

Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Active Pharmaceutical Ingredients (APIs) for the global pharmaceutical companies. It provides value-added services in Contract Research, Custom Synthesis, and Specialties Scientific technology (Green Process, APIs Process Development, Polymorphism, Crystallisation and Purification) for Pharmaceutical and Life Sciences industry.
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Mirogabalin

About the Company : Sichuan Qingmu Pharmaceutical Co., Ltd, is a FDA approved cGMP factory in China, focusing on APIs’ production. The products are mainly Oncology APIs, Cardiovascular APIs, and Vet...

Sichuan Qingmu Pharmaceutical Co., Ltd, is a FDA approved cGMP factory in China, focusing on APIs’ production. The products are mainly Oncology APIs, Cardiovascular APIs, and Veterinary APIs, such as Bisoprolol, Dabigatran, Lenvatinib and Fluralaner with DMFs available. Some products are certified with CEP. Also with our mother factory, we can provide CDMO production from intermediates, APIs to formulations.
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Mirogabalin

About the Company : Zhejiang Bamboo Pharmaceuticals is a new, innovative, green, high-grade pharmaceutical intermediate, API and oral solid formulation pharmaceutical manufacturer which was establishe...

Zhejiang Bamboo Pharmaceuticals is a new, innovative, green, high-grade pharmaceutical intermediate, API and oral solid formulation pharmaceutical manufacturer which was established in 2020. The company is positioned as a modern and regulatory pharmaceutical company with API and formulation drug. The formulation drug are mainly sold to the domestic market, and the goal is to become one of the largest supplier of Chinese "4 + 7" volume procurement in China.
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02-Jun-2023
05-Aug-2024
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Drugs in Development

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Details:

Tarlige® (mirogabalin besilate), is an analgesic works by inhibiting the excessive release of pain-related neurotransmitters in presynaptic nerve terminal, ® was approved for the indication of “peripheral neuropathic pain” in Japan.


Lead Product(s): Mirogabalin Besylate

Therapeutic Area: Neurology Brand Name: Tarlige

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 28, 2022

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ASC 2024
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ASC 2024
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Details : Tarlige® (mirogabalin besilate), is an analgesic works by inhibiting the excessive release of pain-related neurotransmitters in presynaptic nerve terminal, ® was approved for the indication of “peripheral neuropathic pain” in Japan.

Brand Name : Tarlige

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 28, 2022

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INTERMEDIATES SUPPLIERS

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Virtual BoothPorton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

CAS Number : 1235479-61-4

End Use API : Mirogabalin Besylate

About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...

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CAS Number : 1235479-61-4

End Use API : Mirogabalin Besylate

About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...

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NEWS #PharmaBuzz

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http://www.pharmabiz.com/NewsDetails.aspx?aid=147752&sid=2

PHARMABIZ
29 Mar 2022

https://www.biospectrumasia.com/news/25/18875/menarini-to-commercialize-japanese-drug-in-singapore-malaysia-and-the-philippines.html

BIOSPECTRUM ASIA
23 Aug 2021

https://www.daiichisankyo.com/media/press_release/detail/index_4107.html

RUTERS
18 Dec 2020

https://www.daiichisankyo.com/media/press_release/detail/index_4107.html

DAIICHISANKYO
18 Dec 2020

http://www.pmlive.com/pharma_news/daiichi_sankyo_starts_mirogabalin_trial_in_spinal_injury_pain_1282805

Phil Taylor PMLIVE
28 Mar 2019

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