Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
Listed Suppliers
0
API
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Weekly News Recap #Phispers
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
1. 497833-27-9
2. Itf2357
3. Givinostat [inn]
4. Givinostat Free Base
5. Itf-2357
6. [6-(diethylaminomethyl)naphthalen-2-yl]methyl N-[4-(hydroxycarbamoyl)phenyl]carbamate
7. 5p60f84fbh
8. Chembl1213492
9. 497833-27-9 (free Base)
10. (6-((diethylamino)methyl)naphthalen-2-yl)methyl (4-(hydroxycarbamoyl)phenyl)carbamate
11. (6-((diethylamino)methyl)naphthalen-2-yl)methyl(4-(hydroxycarbamoyl)phenyl)carbamate
12. [4-[(hydroxyamino)carbonyl]phenyl]carbamic Acid [6-[(diethylamino)methyl]-2-naphthalenyl]methyl Ester
13. Gavinostat
14. 4-[(hydroxyamino)carbonyl]phenyl]carbamic Acid [6-[(diethylamino)methyl]-2-naphthalenyl]methyl Ester
15. Unii-5p60f84fbh
16. {6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4-(hydroxycarbamoyl)phenyl]carbamate
17. Gavinostat;itf-2357
18. Gtpl7490
19. Schembl1555814
20. Chebi:94187
21. Dtxsid70198049
22. Bcp29856
23. Zinc3820616
24. Bdbm50105329
25. Cs-4727
26. Db12645
27. Ex-5958
28. [6-(diethylaminomethyl)-2-naphthyl]methyl N-[4-(hydroxycarbamoyl)phenyl]carbamate
29. Ac-31380
30. Bcb04_000011
31. Hy-14842
32. Ec-000.2471
33. 833h279
34. A923985
35. Q426257
36. Gavinostat; Itf-2357; Itf2357; Itf 2357
37. Brd-k13810148-001-01-3
38. Carbamic Acid, (4-((hydroxyamino)carbonyl)phenyl)-, (6-((diethylamino)methyl)-2-naphthalenyl)methyl Ester
39. Qcm
| Molecular Weight | 421.5 g/mol |
|---|---|
| Molecular Formula | C24H27N3O4 |
| XLogP3 | 3.6 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 9 |
| Exact Mass | 421.20015635 g/mol |
| Monoisotopic Mass | 421.20015635 g/mol |
| Topological Polar Surface Area | 90.9 Ų |
| Heavy Atom Count | 31 |
| 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 | 1 |
Juvenile idiopathic arthritis
API SUPPLIERS
Click Us!
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37344
Submission : 2023-04-04
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37344
Submission : 2023-04-04
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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
Therapeutic Area: Genetic Disease Brand Name: Duvyzat
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: ITF Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 25, 2024
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
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.
Brand Name : Duvyzat
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 25, 2024
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
Therapeutic Area: Genetic Disease Brand Name: Duvyzat
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2024
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Duvyzat
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 25, 2024
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
Therapeutic Area: Genetic Disease Brand Name: Duvyzat
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2024
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Duvyzat
Molecule Type : Small molecule
Upfront Cash : Not Applicable
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
Therapeutic Area: Genetic Disease Brand Name: ITF2357
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2023
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : ITF2357
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 29, 2023
Details:
ITF2357 (givinostat) is an investigational drug act as a inhibits histone deacetylases (HDACs), which is investigated for the treatment of Duchenne Muscular Dystrophy.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Brand Name: ITF2357
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Syneos Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2023
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Syneos Health
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ITF2357 (givinostat) is an investigational drug act as a inhibits histone deacetylases (HDACs), which is investigated for the treatment of Duchenne Muscular Dystrophy.
Brand Name : ITF2357
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 29, 2023
Details:
The study compared ITF2357 (givinostat) to placebo and met the primary endpoint (change from baseline in the time to climb 4 stairs) following 18 months of treatment in the target population1 with key secondary endpoints consistent with the functional primary endpoint.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Brand Name: ITF2357
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2022
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The study compared ITF2357 (givinostat) to placebo and met the primary endpoint (change from baseline in the time to climb 4 stairs) following 18 months of treatment in the target population1 with key secondary endpoints consistent with the functional pr...
Brand Name : ITF2357
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 25, 2022
Details:
Italfarmaco provided evidence which continues to show a delay in disease progression in DMD boys aged 7-11 years at treatment start, supported by data on the 7-year follow-up period from the long-term study with Givinostat in addition to steroid treatment.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Brand Name: ITF2357
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Italfarmaco provided evidence which continues to show a delay in disease progression in DMD boys aged 7-11 years at treatment start, supported by data on the 7-year follow-up period from the long-term study with Givinostat in addition to steroid treatmen...
Brand Name : ITF2357
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 22, 2021
Details:
Third regulatory designation Italfarmaco has received from the FDA for Givinostat after the Orphan Drug designation and Fast Track designation and reflects the agency’s recognition of Givinostat’s potential to treat DMD, a devastating genetic disease.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Brand Name: ITF2357
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2020
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Third regulatory designation Italfarmaco has received from the FDA for Givinostat after the Orphan Drug designation and Fast Track designation and reflects the agency’s recognition of Givinostat’s potential to treat DMD, a devastating genetic disease...
Brand Name : ITF2357
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 09, 2020
Details:
The Interim data from EPYDIS Phase 3 trial shows that the trial is NOT FUTILE and the Independent Data Monitoring Committee recommends trial continuation.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2020
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The Interim data from EPYDIS Phase 3 trial shows that the trial is NOT FUTILE and the Independent Data Monitoring Committee recommends trial continuation.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 27, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
STOCK RECAP #PipelineProspector
NEWS #PharmaBuzz
ABOUT THIS PAGE
A Givinostat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Givinostat, including repackagers and relabelers. The FDA regulates Givinostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Givinostat API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Givinostat supplier is an individual or a company that provides Givinostat active pharmaceutical ingredient (API) or Givinostat finished formulations upon request. The Givinostat suppliers may include Givinostat API manufacturers, exporters, distributors and traders.
click here to find a list of Givinostat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Givinostat DMF (Drug Master File) is a document detailing the whole manufacturing process of Givinostat active pharmaceutical ingredient (API) in detail. Different forms of Givinostat DMFs exist exist since differing nations have different regulations, such as Givinostat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Givinostat DMF submitted to regulatory agencies in the US is known as a USDMF. Givinostat USDMF includes data on Givinostat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Givinostat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Givinostat suppliers with USDMF on PharmaCompass.
Givinostat 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 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 Givinostat GMP manufacturer or Givinostat GMP API supplier for your needs.
A Givinostat CoA (Certificate of Analysis) is a formal document that attests to Givinostat's compliance with Givinostat specifications and serves as a tool for batch-level quality control.
Givinostat CoA mostly includes findings from lab analyses of a specific batch. For each Givinostat 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Givinostat EP), Givinostat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Givinostat USP).
LOOKING FOR A SUPPLIER?
