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1. Itf 2357
2. Itf2357
1. 199657-29-9
2. Givinostat Hcl
3. Givinostat (hydrochloride)
4. Itf 2357
5. Z02132r2qq
6. Unii-z02132r2qq
7. Itf2357 Hydrochloride
8. Itf-2357 Hydrochloride
9. Histone Deacetylase Inhibitor
10. Itf2357
11. Itf-2357
12. Carbamic Acid, N-[4-[(hydroxyamino)carbonyl]phenyl]-, [6-[(diethylamino)methyl]-2-naphthalenyl]methyl Ester, Hydrochloride (1:1)
13. [6-(diethylaminomethyl)naphthalen-2-yl]methyl N-[4-(hydroxycarbamoyl)phenyl]carbamate;hydrochloride
14. Carbamic Acid, N-(4-((hydroxyamino)carbonyl)phenyl)-, (6-((diethylamino)methyl)-2-naphthalenyl)methyl Ester, Hydrochloride (1:1)
15. (6-((diethylamino)methyl)naphthalen-2-yl)methyl (4-(hydroxycarbamoyl)phenyl)carbamate Hydrochloride
16. Mfcd28502062
17. {6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4-(hydroxycarbamoyl)phenyl]carbamate Hydrochloride
18. Itf 2357 Hydrochloride
19. Givinostat Monohydrochloride
20. Schembl23529420
21. Givinostat Hydrochloride Anhydrous
22. Chebi:231333
23. Ex-a8024
24. Zha65729
25. Hy-14842a
26. Akos030526700
27. Cs-4728
28. Sb16937
29. As-52365
30. En300-257964
31. P14959
32. Q27294820
33. Z2327390266
34. (6-((diethylamino)methyl)naphthalen-2-yl)methyl 4-(hydroxycarbamoyl)phenylcarbamate Hydrochloride
35. [6-[(diethylamino)methyl]-2-naphthalenyl]methyl N-[4-[(hydroxyamino)carbonyl]phenyl]carbamate Hydrochloride (1:1)
36. {6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4-(hydroxycarbamoyl)phenyl]carbamate--hydrogen Chloride
37. {6-[(diethylamino)methyl]naphthalen-2-yl}methyl N-[4-(hydroxycarbamoyl)phenyl]carbamate Hydrochloride
1. Givinostat
| Molecular Weight | 457.9 g/mol |
|---|---|
| Molecular Formula | C24H28ClN3O4 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 9 |
| Exact Mass | Da |
| Monoisotopic Mass | Da |
| Topological Polar Surface Area | 90.9 |
| Heavy Atom Count | 32 |
| Formal Charge | 0 |
| Complexity | 575 |
| 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 | 2 |
Histone Deacetylase Inhibitors
Compounds that inhibit HISTONE DEACETYLASES. This class of drugs may influence gene expression by increasing the level of acetylated HISTONES in specific CHROMATIN domains. (See all compounds classified as Histone Deacetylase Inhibitors.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37344
Submission : 2023-04-04
Status : Active
Type : II







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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37344
Submission : 2023-04-04
Status : Active
Type : II

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Details:
Multicare Pharma will support the regulatory approval in Brazil and distribute Duvyzat (givinostat), Italfarmaco’s novel histone deacetylase (HDAC) inhibitor to treat Duchenne muscular dystrophy.
Lead Product(s): Givinostat HCl,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Duvyzat
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Multicare
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 16, 2025

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Lead Product(s) : Givinostat HCl,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Multicare
Deal Size : Undisclosed
Deal Type : Agreement
Italfarmaco Announces Exclusive Distribution Agreement with Multicare Pharma in Brazil
Details : Multicare Pharma will support the regulatory approval in Brazil and distribute Duvyzat (givinostat), Italfarmaco’s novel histone deacetylase (HDAC) inhibitor to treat Duchenne muscular dystrophy.
Product Name : Duvyzat
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 16, 2025

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Details:
Duvyzat (givinostat HCl)is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
Lead Product(s): Givinostat HCl,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Duvyzat
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 06, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Lead Product(s) : Givinostat HCl,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
European Commission Approves Duvyzat for the Treatment of Duchenne Muscular Dystrophy
Details : Duvyzat (givinostat HCl)is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
Product Name : Duvyzat
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 06, 2025

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Details:
Duvyzat (givinostat HCl) is a histone deacetylase inhibitor, being investigated for the treatment of polycythaemia vera.
Lead Product(s): Givinostat HCl,Inapplicable
Therapeutic Area: Oncology Brand Name: Duvyzat
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 06, 2025

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Lead Product(s) : Givinostat HCl,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Italfarmaco gets Fast Track Tag for Givinostat in Polycythemia Vera Treatment
Details : Duvyzat (givinostat HCl) is a histone deacetylase inhibitor, being investigated for the treatment of polycythaemia vera.
Product Name : Duvyzat
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 06, 2025

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Details:
Duvyzat (givinostat) is a novel histone deacetylase (HDAC) inhibitor, which is being evaluated for the treatment of patients 6 years or older with Duchenne muscular dystrophy.
Lead Product(s): Givinostat HCl,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Duvyzat
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 25, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Lead Product(s) : Givinostat HCl,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
CHMP Recommends EU Approval for Duvyzat to Treat Duchenne Muscular Dystrophy
Details : Duvyzat (givinostat) is a novel histone deacetylase (HDAC) inhibitor, which is being evaluated for the treatment of patients 6 years or older with Duchenne muscular dystrophy.
Product Name : Duvyzat
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 25, 2025

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Details:
Under the agreement, Medis will have exclusive distribution rights of Duvyzat (Givinostat HCl). It is being indicated for the treatment of DMD.
Lead Product(s): Givinostat HCl,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Duvyzat
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Medis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 18, 2025

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Lead Product(s) : Givinostat HCl,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Medis
Deal Size : Undisclosed
Deal Type : Agreement
Italfarmaco, Medis Sign Exclusive Deal for Givinostat in 17 European Nations
Details : Under the agreement, Medis will have exclusive distribution rights of Duvyzat (Givinostat HCl). It is being indicated for the treatment of DMD.
Product Name : Duvyzat
Product Type : Miscellaneous
Upfront Cash : Undisclosed
March 18, 2025

Details:
Givinostat HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Muscular Dystrophy, Duchenne.
Lead Product(s): Givinostat HCl,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Fortrea
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 10, 2025

Lead Product(s) : Givinostat HCl,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Fortrea
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Givinostat HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Muscular Dystrophy, Duchenne.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 10, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Details:
Duvyzat (givinostat) is a novel histone deacetylase (HDAC) inhibitor, which is being evaluated for the treatment of patients 6 years or older with Duchenne muscular dystrophy.
Lead Product(s): Givinostat HCl,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Duvyzat
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 25, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Lead Product(s) : Givinostat HCl,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
ITF Therapeutics Announces U.S. Availability of DUVYZAT™ for Duchenne Muscular Dystrophy
Details : Duvyzat (givinostat) is a novel histone deacetylase (HDAC) inhibitor, which is being evaluated for the treatment of patients 6 years or older with Duchenne muscular dystrophy.
Product Name : Duvyzat
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 25, 2024

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Details:
PANTHERx partners with ITF for the U.S. distribution of Duvyzat (givinostat), the approved product to treat patients with all genetic variants of Duchenne muscular dystrophy aged six years and older.
Lead Product(s): Givinostat HCl,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Duvyzat
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: ITF Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 25, 2024

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Lead Product(s) : Givinostat HCl,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : ITF Therapeutics
Deal Size : Undisclosed
Deal Type : Partnership
PANTHERx®Rare Partnering with ITF Therapeutics LLC for U.S. Distribution of DUVYZAT™
Details : PANTHERx partners with ITF for the U.S. distribution of Duvyzat (givinostat), the approved product to treat patients with all genetic variants of Duchenne muscular dystrophy aged six years and older.
Product Name : Duvyzat
Product Type : Miscellaneous
Upfront Cash : Undisclosed
July 25, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Details:
Duvyzat (givinostat) is a novel histone deacetylase (HDAC) inhibitor, which is being evaluated for the treatment of patients 6 years or older with Duchenne muscular dystrophy.
Lead Product(s): Givinostat HCl,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Duvyzat
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 21, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Givinostat HCl,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Italfarmaco Receives FDA Approval for Duvyzat™ (givinostat) in Duchenne Muscular Dystrophy
Details : Duvyzat (givinostat) is a novel histone deacetylase (HDAC) inhibitor, which is being evaluated for the treatment of patients 6 years or older with Duchenne muscular dystrophy.
Product Name : Duvyzat
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 21, 2024

Details:
ITF2357 (givinostat) is an HDAC Inhibitor small molecule drug, currently being investigated as an oral suspension for the treatment of Duchenne Muscular Dystrophy.
Lead Product(s): Givinostat HCl,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 29, 2023

Lead Product(s) : Givinostat HCl,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Italfarmaco Group Announces New PDUFA Date for Givinostat DMD NDA
Details : ITF2357 (givinostat) is an HDAC Inhibitor small molecule drug, currently being investigated as an oral suspension for the treatment of Duchenne Muscular Dystrophy.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 29, 2023

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30 Jan 2025

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PharmaCompass offers a list of Givinostat HCl API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Givinostat HCl manufacturer or Givinostat HCl supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Givinostat HCl manufacturer or Givinostat HCl supplier.
A Givinostat HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Givinostat HCl, including repackagers and relabelers. The FDA regulates Givinostat HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Givinostat HCl 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 Givinostat HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Givinostat HCl supplier is an individual or a company that provides Givinostat HCl active pharmaceutical ingredient (API) or Givinostat HCl finished formulations upon request. The Givinostat HCl suppliers may include Givinostat HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Givinostat HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Givinostat HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Givinostat HCl active pharmaceutical ingredient (API) in detail. Different forms of Givinostat HCl DMFs exist exist since differing nations have different regulations, such as Givinostat HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Givinostat HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Givinostat HCl USDMF includes data on Givinostat HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Givinostat HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Givinostat HCl suppliers with USDMF on PharmaCompass.
Givinostat HCl 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 Givinostat HCl GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Givinostat HCl GMP manufacturer or Givinostat HCl GMP API supplier for your needs.
A Givinostat HCl CoA (Certificate of Analysis) is a formal document that attests to Givinostat HCl's compliance with Givinostat HCl specifications and serves as a tool for batch-level quality control.
Givinostat HCl CoA mostly includes findings from lab analyses of a specific batch. For each Givinostat HCl 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.
Givinostat HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Givinostat HCl EP), Givinostat HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Givinostat HCl USP).