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Synopsis

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Chemistry

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Also known as: 853400-76-7, Nnz-2566, Trofinetide [inn], Trofinetide [usan], Z2me8f52ql, L-glutamic acid, glycyl-2-methyl-l-prolyl-
Molecular Formula
C13H21N3O6
Molecular Weight
315.32  g/mol
InChI Key
BUSXWGRAOZQTEY-SDBXPKJASA-N
FDA UNII
Z2ME8F52QL

Trofinetide
Trofinetide (NNZ-2566), a neuroprotective analogue of [glypromate], is a novel molecule that has a profile suitable for both intravenous infusion and chronic oral delivery. It is currently in development to treat traumatic brain injury.
1 2D Structure

Trofinetide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-[[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino]pentanedioic acid
2.1.2 InChI
InChI=1S/C13H21N3O6/c1-13(5-2-6-16(13)9(17)7-14)12(22)15-8(11(20)21)3-4-10(18)19/h8H,2-7,14H2,1H3,(H,15,22)(H,18,19)(H,20,21)/t8-,13-/m0/s1
2.1.3 InChI Key
BUSXWGRAOZQTEY-SDBXPKJASA-N
2.1.4 Canonical SMILES
CC1(CCCN1C(=O)CN)C(=O)NC(CCC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
C[C@]1(CCCN1C(=O)CN)C(=O)N[C@@H](CCC(=O)O)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
Z2ME8F52QL
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Glycyl-l-2-methylprolyl-l-glutamic Acid

2.3.2 Depositor-Supplied Synonyms

1. 853400-76-7

2. Nnz-2566

3. Trofinetide [inn]

4. Trofinetide [usan]

5. Z2me8f52ql

6. L-glutamic Acid, Glycyl-2-methyl-l-prolyl-

7. Acp-2566

8. ((s)-1-glycyl-2-methylpyrrolidine-2-carbonyl)-l-glutamic Acid

9. Unii-z2me8f52ql

10. Nnz 2566

11. Glycyl-l-2-methylprolyl-l-glutamic Acid

12. Glycyl-2-methyl-l-prolyl-l-glutamic Acid

13. Trofinetide(nnz2566)

14. Trofinetide [who-dd]

15. Chembl197084

16. Schembl1170014

17. Gly-2-methyl-l-pro-l-glu-oh

18. Dtxsid101336041

19. Who 10076

20. Cs-8154

21. Db06045

22. Hy-16757

23. A16972

24. Q27294917

25. (2s)-2-[[(2s)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino]pentanedioic Acid

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 315.32 g/mol
Molecular Formula C13H21N3O6
XLogP3-3.9
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count7
Rotatable Bond Count7
Exact Mass315.14303540 g/mol
Monoisotopic Mass315.14303540 g/mol
Topological Polar Surface Area150 Ų
Heavy Atom Count22
Formal Charge0
Complexity480
Isotope Atom Count0
Defined Atom Stereocenter Count2
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

Investigated for use/treatment in traumatic brain injuries.


5 Pharmacology and Biochemistry
5.1 Pharmacology

NNZ-2566 is shown to have multi-faceted action to significantly reduce both inflammation and apoptosis (cell death), protecting the neurons and their surrounding infrastructure.


API SUPPLIERS

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01

Omgene Life Sciences Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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02

Global Pharma Tek

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
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03

Conscientia Industrial

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
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04

Sandoo Pharmaceuticals and Chemcia...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
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05

Flamma SpA

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
Not Confirmed
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Flamma SpA

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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06

Maithri Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
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07

F.I.S. Fabbrica Italiana Sintetici

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
Not Confirmed
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F.I.S. Fabbrica Italiana Sintetici

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Iran Expo
Not Confirmed
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Corden Pharma Bergamo S.p.A

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
Not Confirmed
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Corden Pharma Bergamo S.p.A

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Listed Suppliers

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Trofinetide

About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
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Iran Expo
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Trofinetide

About the Company : Conscientia Industrial is a pharmaceutical company, mainly developing, manufacturing, marketing APIs (Active Pharmaceutical Ingredients), intermediates, fine chemicals in China. We...

Conscientia Industrial is a pharmaceutical company, mainly developing, manufacturing, marketing APIs (Active Pharmaceutical Ingredients), intermediates, fine chemicals in China. We started business in early 2010, producing and providing products for both human and veterinary health at home and abroad. Conscientia Industrial makes regular productions and also provides custom synthesis, contract manufacturing services. We have series of products, such as Hormones, Prostaglandins, Peptides, Anti-cancer, Anti-tumor, Anti-virus, Anti-diabetic APIs and their related intermediates, impurities, chemicals.
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Trofinetide

About the Company : Global PharmaTek (GPT) was founded in the year 2011 and is a service provider conglomerate in Staffing, Clinical Research, and Trading. The company has its presence in USA, Canada...

Global PharmaTek (GPT) was founded in the year 2011 and is a service provider conglomerate in Staffing, Clinical Research, and Trading. The company has its presence in USA, Canada, India and Europe. GPT is committed to providing path-breaking innovations when it comes to offering new-age services through a range of businesses and is renowned for setting unique benchmarks in technology, research, design, and quality services. Over the past ten years, GPT has established a reputation as one of the most innovative and respectable service providers.
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Trofinetide

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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Trofinetide

About the Company : Sandoo Pharmaceuticals and Chemcials Co.,Ltd was established in 2009, with a young and active team, located in Ningbo, China. Specializes in exporting and importing pharmaceutica...

Sandoo Pharmaceuticals and Chemcials Co.,Ltd was established in 2009, with a young and active team, located in Ningbo, China. Specializes in exporting and importing pharmaceutical intermediates and chemical products as well as active pharmaceutical ingredients.
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Patents & EXCLUSIVITIES

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US Patents

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01

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TROFINETIDE

US Patent Number : 9212204

Drug Substance Claim :

Drug Product Claim :

Application Number : 217026

Patent Use Code : U-3556

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-01-27

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TROFINETIDE

US Patent Number : 11827600

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217026

Patent Use Code : U-3556

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2042-07-12

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TROFINETIDE

US Patent Number : 11370755

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217026

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-08-03

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ABOUT THIS PAGE

Looking for 853400-76-7 / Trofinetide API manufacturers, exporters & distributors?

Trofinetide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Trofinetide 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 Trofinetide manufacturer or Trofinetide supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trofinetide manufacturer or Trofinetide supplier.

PharmaCompass also assists you with knowing the Trofinetide API Price utilized in the formulation of products. Trofinetide API Price is not always fixed or binding as the Trofinetide Price is obtained through a variety of data sources. The Trofinetide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Trofinetide

Synonyms

853400-76-7, Nnz-2566, Trofinetide [inn], Trofinetide [usan], Z2me8f52ql, L-glutamic acid, glycyl-2-methyl-l-prolyl-

Cas Number

853400-76-7

Unique Ingredient Identifier (UNII)

Z2ME8F52QL

About Trofinetide

Trofinetide (NNZ-2566), a neuroprotective analogue of [glypromate], is a novel molecule that has a profile suitable for both intravenous infusion and chronic oral delivery. It is currently in development to treat traumatic brain injury.

Trofinetide Manufacturers

A Trofinetide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trofinetide, including repackagers and relabelers. The FDA regulates Trofinetide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trofinetide 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 Trofinetide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Trofinetide Suppliers

A Trofinetide supplier is an individual or a company that provides Trofinetide active pharmaceutical ingredient (API) or Trofinetide finished formulations upon request. The Trofinetide suppliers may include Trofinetide API manufacturers, exporters, distributors and traders.

click here to find a list of Trofinetide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Trofinetide NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Trofinetide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Trofinetide API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Trofinetide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Trofinetide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trofinetide NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Trofinetide suppliers with NDC on PharmaCompass.

Trofinetide GMP

Trofinetide 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 Trofinetide 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 Trofinetide GMP manufacturer or Trofinetide GMP API supplier for your needs.

Trofinetide CoA

A Trofinetide CoA (Certificate of Analysis) is a formal document that attests to Trofinetide's compliance with Trofinetide specifications and serves as a tool for batch-level quality control.

Trofinetide CoA mostly includes findings from lab analyses of a specific batch. For each Trofinetide 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.

Trofinetide may be tested according to a variety of international standards, such as European Pharmacopoeia (Trofinetide EP), Trofinetide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trofinetide 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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