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Chemistry

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Also known as: Ag-348 sulfate hydrate, Mitapivat sulfate [usan], N4jta67v3o, Pyrukynd, Ag-348 hemisulfate sesquihydrate, Mitapivat sulfate (usan)
Molecular Formula
C48H60N8O13S3
Molecular Weight
1053.2  g/mol
InChI Key
DMRIPASJCJRBMV-UHFFFAOYSA-N
FDA UNII
N4JTA67V3O

Mitapivat
1 2D Structure

Mitapivat

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[4-[4-(cyclopropylmethyl)piperazine-1-carbonyl]phenyl]quinoline-8-sulfonamide;sulfuric acid;trihydrate
2.1.2 InChI
InChI=1S/2C24H26N4O3S.H2O4S.3H2O/c2*29-24(28-15-13-27(14-16-28)17-18-6-7-18)20-8-10-21(11-9-20)26-32(30,31)22-5-1-3-19-4-2-12-25-23(19)22;1-5(2,3)4;;;/h2*1-5,8-12,18,26H,6-7,13-17H2;(H2,1,2,3,4);3*1H2
2.1.3 InChI Key
DMRIPASJCJRBMV-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CC1CN2CCN(CC2)C(=O)C3=CC=C(C=C3)NS(=O)(=O)C4=CC=CC5=C4N=CC=C5.C1CC1CN2CCN(CC2)C(=O)C3=CC=C(C=C3)NS(=O)(=O)C4=CC=CC5=C4N=CC=C5.O.O.O.OS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
N4JTA67V3O
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 8-quinolinesulfonamide, N-(4-((4-(cyclopropylmethyl)-1-piperazinyl)carbonyl)phenyl)-

2. Ag-348

3. Mitapivat

4. Mitapivat Hemisulfate Sesquihydrate

5. N-(4-((4-(cyclopropylmethyl)-1-piperazinyl)carbonyl)phenyl)-8-quinolinesulfonamide

6. N-(4-(4-(cyclopropylmethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide

7. Pyrukynd

2.3.2 Depositor-Supplied Synonyms

1. Ag-348 Sulfate Hydrate

2. Mitapivat Sulfate [usan]

3. N4jta67v3o

4. Pyrukynd

5. Ag-348 Hemisulfate Sesquihydrate

6. Mitapivat Sulfate (usan)

7. 2151847-10-6

8. 8-quinolinesulfonamide, N-(4-((4-(cyclopropylmethyl)-1-piperazinyl)carbonyl)phenyl)-, Sulfate, Hydrate (2:1:3)

9. N-(4-(4-(cyclopropylmethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide Sulfate Hydrate (2:1:3)

10. Unii-n4jta67v3o

11. Chembl4297223

12. Mitapivat Hemisulfate Sesquihydrate

13. D11408

2.4 Create Date
2018-08-12
3 Chemical and Physical Properties
Molecular Weight 1053.2 g/mol
Molecular Formula C48H60N8O13S3
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count19
Rotatable Bond Count12
Exact Mass1052.34419752 g/mol
Monoisotopic Mass1052.34419752 g/mol
Topological Polar Surface Area268 Ų
Heavy Atom Count72
Formal Charge0
Complexity831
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count6
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Enzyme Activators

Compounds or factors that act on a specific enzyme to increase its activity. (See all compounds classified as Enzyme Activators.)


API SUPPLIERS

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01

Nuray Chemicals Private Limited

India

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

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  • EDQM
  • WHO-GMP

Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Nuray Chemicals

02

Maithri Drugs

India

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

Biotech Digital Meet
Not Confirmed
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Maithri Drugs

India

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

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Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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Listed Suppliers

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Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Digital Content Digital Content

Mitapivat

About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.
Nuray Chemicals

02

Biotech Digital Meet
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Mitapivat

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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Drugs in Development

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Details:

Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is under phase 3 development for the treatment of children with PK deficiency who are regularly transfused.


Lead Product(s): Mitapivat

Therapeutic Area: Genetic Disease Brand Name: Pyrukynd

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 13, 2025

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01

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

Details : Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is under phase 3 development for the treatment of children with PK deficiency who are regularly transfused.

Product Name : Pyrukynd

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 13, 2025

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Details:

Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is being developed for adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.


Lead Product(s): Mitapivat

Therapeutic Area: Hematology Brand Name: Pyrukynd

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 08, 2025

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02

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

Details : Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is being developed for adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.

Product Name : Pyrukynd

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 08, 2025

blank

Details:

Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is under phase 3 clinical development for the treatment of pateints with sickle cell disease.


Lead Product(s): Mitapivat

Therapeutic Area: Hematology Brand Name: Pyrukynd

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 18, 2024

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03

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

Details : Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is under phase 3 clinical development for the treatment of pateints with sickle cell disease.

Product Name : Pyrukynd

Product Type : Small molecule

Upfront Cash : Not Applicable

December 18, 2024

blank

Details:

Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is under phase 3 clinical development for the treatment of pateints with sickle cell disease.


Lead Product(s): Mitapivat

Therapeutic Area: Hematology Brand Name: Pyrukynd

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 23, 2024

blank

04

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

Details : Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is under phase 3 clinical development for the treatment of pateints with sickle cell disease.

Product Name : Pyrukynd

Product Type : Small molecule

Upfront Cash : Not Applicable

October 23, 2024

blank

Details:

Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is under phase 3 development for the treatment of children aged 1 to <18 years with PK deficiency who are regularly transfused.


Lead Product(s): Mitapivat

Therapeutic Area: Genetic Disease Brand Name: Pyrukynd

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 01, 2024

blank

05

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

Details : Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is under phase 3 development for the treatment of children aged 1 to <18 years with PK deficiency who are regularly transfused.

Product Name : Pyrukynd

Product Type : Small molecule

Upfront Cash : Not Applicable

August 01, 2024

blank

Details:

Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is under phase 3 clinical development for the treatment of non-transfusion-dependent alpha- or beta-thalassemia.


Lead Product(s): Mitapivat

Therapeutic Area: Genetic Disease Brand Name: Pyrukynd

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 03, 2024

blank

06

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

Details : Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator. It is under phase 3 clinical development for the treatment of non-transfusion-dependent alpha- or beta-thalassemia.

Product Name : Pyrukynd

Product Type : Small molecule

Upfront Cash : Not Applicable

June 03, 2024

blank

Details:

Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator under phase 3 development for treating hemolytic anemia and non-transfusion-dependent thalassemia.


Lead Product(s): Mitapivat

Therapeutic Area: Rare Diseases and Disorders Brand Name: Pyrukynd

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 03, 2024

blank

07

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

Details : Pyrukynd (mitapivat sulfate) is a pyruvate kinase activator under phase 3 development for treating hemolytic anemia and non-transfusion-dependent thalassemia.

Product Name : Pyrukynd

Product Type : Small molecule

Upfront Cash : Not Applicable

January 03, 2024

blank

Details:

PYRUKYND (mitapivat sulfate) is a pyruvate kinase activator and indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.


Lead Product(s): Mitapivat

Therapeutic Area: Hematology Brand Name: Pyrukynd

Study Phase: Phase II/ Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 26, 2023

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08

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

Details : PYRUKYND (mitapivat sulfate) is a pyruvate kinase activator and indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

Product Name : Pyrukynd

Product Type : Small molecule

Upfront Cash : Not Applicable

June 26, 2023

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Details:

PYRUKYND® is a first-in-class, oral PK activator and the first approved disease-modifying therapy for patients in the EU with this rare, debilitating, lifelong hemolytic anemia.


Lead Product(s): Mitapivat

Therapeutic Area: Hematology Brand Name: Pyrukynd

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 10, 2022

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09

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

Details : PYRUKYND® is a first-in-class, oral PK activator and the first approved disease-modifying therapy for patients in the EU with this rare, debilitating, lifelong hemolytic anemia.

Product Name : Pyrukynd

Product Type : Small molecule

Upfront Cash : Not Applicable

November 10, 2022

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Details:

PYRUKYND® (mitapivat sulfate) demonstrated a significant increase in hemoglobin in patients with PK deficiency who are not regularly transfused. 40 percent of patients randomized to PYRUKYND® achieved a hemoglobin response, compared to 0 patients randomized to placebo.


Lead Product(s): Mitapivat

Therapeutic Area: Genetic Disease Brand Name: Pyrukynd

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 16, 2022

blank

10

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

Details : PYRUKYND® (mitapivat sulfate) demonstrated a significant increase in hemoglobin in patients with PK deficiency who are not regularly transfused. 40 percent of patients randomized to PYRUKYND® achieved a hemoglobin response, compared to 0 patients rando...

Product Name : Pyrukynd

Product Type : Small molecule

Upfront Cash : Not Applicable

September 16, 2022

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ABOUT THIS PAGE

Looking for 2151847-10-6 / Mitapivat API manufacturers, exporters & distributors?

Mitapivat manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mitapivat

Synonyms

Ag-348 sulfate hydrate, Mitapivat sulfate [usan], N4jta67v3o, Pyrukynd, Ag-348 hemisulfate sesquihydrate, Mitapivat sulfate (usan)

Cas Number

2151847-10-6

Unique Ingredient Identifier (UNII)

N4JTA67V3O

Mitapivat Manufacturers

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

Mitapivat Suppliers

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

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

Mitapivat USDMF

A Mitapivat DMF (Drug Master File) is a document detailing the whole manufacturing process of Mitapivat active pharmaceutical ingredient (API) in detail. Different forms of Mitapivat DMFs exist exist since differing nations have different regulations, such as Mitapivat USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Mitapivat DMF submitted to regulatory agencies in the US is known as a USDMF. Mitapivat USDMF includes data on Mitapivat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mitapivat USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Mitapivat suppliers with USDMF on PharmaCompass.

Mitapivat GMP

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

Mitapivat CoA

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

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

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