Synopsis
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NDC API
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Europe
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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
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
Molecular Weight | 1053.2 g/mol |
---|---|
Molecular Formula | C48H60N8O13S3 |
Hydrogen Bond Donor Count | 7 |
Hydrogen Bond Acceptor Count | 19 |
Rotatable Bond Count | 12 |
Exact Mass | 1052.34419752 g/mol |
Monoisotopic Mass | 1052.34419752 g/mol |
Topological Polar Surface Area | 268 Ų |
Heavy Atom Count | 72 |
Formal Charge | 0 |
Complexity | 831 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 6 |
Enzyme Activators
Compounds or factors that act on a specific enzyme to increase its activity. (See all compounds classified as Enzyme Activators.)
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39774
Submission : 2024-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39774
Submission : 2024-03-31
Status : Active
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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...
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...
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
Lead Product(s) : Mitapivat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Agios' Mitapivat Meets Primary Goal in Phase 3 ACTIVATE-Kids PK Deficiency Study
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
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
Lead Product(s) : Mitapivat
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Agios Receives FDA Acceptance for PYRUKYND® in Thalassemia
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
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
Lead Product(s) : Mitapivat
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
EU Commission Grants Orphan Drug Designation To Agios' Mitapivat for Sickle Cell Disease
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
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
Lead Product(s) : Mitapivat
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Agios Completes Enrollment of Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease
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
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
Lead Product(s) : Mitapivat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Agios Announces Phase 3 ACTIVATE-KidsT Results for Mitapivat in PK Deficiency
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
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
Lead Product(s) : Mitapivat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Agios’ Mitapivat Meets All Key Endpoints in Phase 3 ENERGIZE-T Study for Thalassemia
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
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
Lead Product(s) : Mitapivat
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Agios Reports Phase 3 ENERGIZE Study Success for Mitapivat in Thalassemia
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
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
Lead Product(s) : Mitapivat
Therapeutic Area : Hematology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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
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
Lead Product(s) : Mitapivat
Therapeutic Area : Hematology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
PYRUKYND® (mitapivat) Approved in the EU for the Treatment of Pyruvate Kinase (PK) Deficiency in ...
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
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
Lead Product(s) : Mitapivat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Agios Receives Positive CHMP Opinion for PYRUKYND® (mitapivat) for the Treatment of Pyruvate Kina...
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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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.
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.
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.
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 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.
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).