Synopsis
Synopsis
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USDMF
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CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Australia
0
South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
US Medicaid
NA
Annual Reports
NA
Regulatory FDF Prices
NA
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API
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FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
1. Schembl18578260
2. Bdbm386574
3. Us10287301, Compound 518
4. (2r,4s)-1-(2-(3- Acetyl-5-(2- Methylpyrimidin- 5-yl)-1h-indazol- 1-yl)acetyl)-n-(6- Bromopyridin-2- Yl)-4- Fluoropyrrolidine- 2-carboxamide
| Molecular Weight | 580.4 g/mol |
|---|---|
| Molecular Formula | C26H23BrFN7O3 |
| XLogP3 | 3.3 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 6 |
| Exact Mass | 579.10298 g/mol |
| Monoisotopic Mass | 579.10298 g/mol |
| Topological Polar Surface Area | 123 Ų |
| Heavy Atom Count | 38 |
| Formal Charge | 0 |
| Complexity | 891 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Details:
Danicopan is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hemoglobinuria, Paroxysmal.
Lead Product(s): Danicopan,Inapplicable
Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 07, 2024
Lead Product(s) : Danicopan,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Danicopan is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hemoglobinuria, Paroxysmal.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 07, 2024
Details:
Voydeya (danicopan) is a first-in-class oral medicine in development as an add-on to C5 inhibitors for patients with PNH and residual hemolytic anemia.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Voydeya
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 23, 2024
Lead Product(s) : Danicopan,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
VOYDEYA Approved in EU as Add-On to Ravulizumab for PNH Patients
Details : Voydeya (danicopan) is a first-in-class oral medicine in development as an add-on to C5 inhibitors for patients with PNH and residual hemolytic anemia.
Product Name : Voydeya
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 23, 2024
Details:
Voydeya (danicopan) is a first-in-class oral medicine being developed as an add-on to C5 inhibitors for patients with PNH and residual hemolytic anemia.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Voydeya
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 01, 2024
Lead Product(s) : Danicopan,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
VOYDEYA™ Approved in US as Add-On Therapy for PNH Extravascular Hemolysis
Details : Voydeya (danicopan) is a first-in-class oral medicine being developed as an add-on to C5 inhibitors for patients with PNH and residual hemolytic anemia.
Product Name : Voydeya
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 01, 2024
Details:
Voydeya (danicopan) is an investigational oral medicine being developed as an add-on to C5 inhibitors for patients with PNH and residual hemolytic anemia.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Voydeya
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2024
Lead Product(s) : Danicopan,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Voydeya Recommended for EU Approval as Add-On Treatment for PNH Patients
Details : Voydeya (danicopan) is an investigational oral medicine being developed as an add-on to C5 inhibitors for patients with PNH and residual hemolytic anemia.
Product Name : Voydeya
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 26, 2024
Details:
Voydeya (danicopan) is a first-in-class oral Factor D inhibitor. It is approved in combination with Ultomiris or Soliris for the treatment of paroxysmal nocturnal haemoglobinuria (PNH).
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Voydeya
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 19, 2024
Lead Product(s) : Danicopan,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
AZ's Newest PNH med Voydeya Approved in Japan
Details : Voydeya (danicopan) is a first-in-class oral Factor D inhibitor. It is approved in combination with Ultomiris or Soliris for the treatment of paroxysmal nocturnal haemoglobinuria (PNH).
Product Name : Voydeya
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 19, 2024
Details:
Danicopan is an investigational oral medicine in development as an add-on to C5 inhibitor therapy eculizumab or ravulizumab for patients with paroxysmal nocturnal hemoglobinuria (PNH) who experience clinically significant extravascular haemolysis.
Lead Product(s): Danicopan,Eculizumab,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Voydeya
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 11, 2023
Lead Product(s) : Danicopan,Eculizumab,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Danicopan is an investigational oral medicine in development as an add-on to C5 inhibitor therapy eculizumab or ravulizumab for patients with paroxysmal nocturnal hemoglobinuria (PNH) who experience clinically significant extravascular haemolysis.
Product Name : Voydeya
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 11, 2023
Details:
Danicopan is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Hemoglobinuria, Paroxysmal.
Lead Product(s): Danicopan,Inapplicable
Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 09, 2023
Lead Product(s) : Danicopan,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Danicopan Early Access Program
Details : Danicopan is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Hemoglobinuria, Paroxysmal.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 09, 2023
Details:
ALXN2040 (danicopan) is an investigational oral medicine in development as an add-on to standard of care C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) for patients with PNH who experience clinically significant EVH.
Lead Product(s): Danicopan,Eculizumab,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Voydeya
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Alexion Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 09, 2023
Lead Product(s) : Danicopan,Eculizumab,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Alexion Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ALXN2040 (danicopan) is an investigational oral medicine in development as an add-on to standard of care C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) for patients with PNH who experience clinically significant EVH.
Product Name : Voydeya
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 09, 2023
Details:
The Phase III trial evaluating danicopan (ALXN2040) met its primary endpoint of change in haemoglobin from baseline at 12 weeks and key secondary endpoints, including transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: AstraZeneca
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 16, 2022
Lead Product(s) : Danicopan,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The Phase III trial evaluating danicopan (ALXN2040) met its primary endpoint of change in haemoglobin from baseline at 12 weeks and key secondary endpoints, including transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy (F...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 16, 2022
Details:
Danicopan (ALXN2040) plus ULTOMIRIS or SOLIRIS demonstrated superiority compared to placebo plus ULTOMIRIS or SOLIRIS for specific population and clinically meaningful improvements in hb levels, transfusion avoidance and FACIT Fatigue scores from baseline.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 16, 2022
Lead Product(s) : Danicopan,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Danicopan (ALXN2040) Add-On to ULTOMIRIS® (ravulizumab-cwvz) or SOLIRIS® (eculizumab) Met Primar...
Details : Danicopan (ALXN2040) plus ULTOMIRIS or SOLIRIS demonstrated superiority compared to placebo plus ULTOMIRIS or SOLIRIS for specific population and clinically meaningful improvements in hb levels, transfusion avoidance and FACIT Fatigue scores from baselin...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 16, 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : RX
Registration Country : USA
Brand Name : VOYDEYA
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Packaging :
Approval Date : 2024-03-29
Application Number : 218037
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VOYDEYA
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Packaging :
Approval Date : 2024-03-29
Application Number : 218037
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Voydeya
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg/100mg
Packaging :
Approval Date : 30/04/2024
Application Number : 69301
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Voydeya
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 30/04/2024
Application Number : 69301
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Voydeya
Dosage Form : Film-Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Voydeya
Dosage Form : Film-Coated Tablet
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Voydeya
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date : 14-06-2024
Application Number : 1241792003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Voydeya
Dosage Form : Tablet
Dosage Strength : 50MG; 100 MG
Packaging :
Approval Date : 14-06-2024
Application Number : 1241792001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Voydeya
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 19-04-2024
Application Number : 28106935823
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Voydeya
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg; 100mg
Packaging :
Approval Date : 19-04-2024
Application Number : 28106935723
Regulatory Info : Prescription
Registration Country : Denmark
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : VOYDEYA
Dosage Form : TABLET
Dosage Strength : 150MG/DOSE
Packaging :
Approval Date :
Application Number : 2550040
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : VOYDEYA
Dosage Form : TABLET
Dosage Strength : 200MG/DOSE
Packaging :
Approval Date :
Application Number : 2550059
Regulatory Info : Prescription
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2035-02-25
US Patent Number : 9796741
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 218037
Patent Use Code : U-3933
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-02-25
Patent Expiration Date : 2038-08-02
US Patent Number : 12076319
Drug Substance Claim :
Drug Product Claim :
Application Number : 218037
Patent Use Code : U-3933
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-08-02
Patent Expiration Date : 2038-08-02
US Patent Number : 12076319
Drug Substance Claim :
Drug Product Claim :
Application Number : 218037
Patent Use Code : U-3933
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-08-02
Patent Expiration Date : 2035-02-25
US Patent Number : 9796741
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 218037
Patent Use Code : U-3933
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-02-25
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
37
PharmaCompass offers a list of Danicopan 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 Danicopan manufacturer or Danicopan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Danicopan manufacturer or Danicopan supplier.
PharmaCompass also assists you with knowing the Danicopan API Price utilized in the formulation of products. Danicopan API Price is not always fixed or binding as the Danicopan Price is obtained through a variety of data sources. The Danicopan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Danicopan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Danicopan, including repackagers and relabelers. The FDA regulates Danicopan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Danicopan 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 Danicopan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Danicopan supplier is an individual or a company that provides Danicopan active pharmaceutical ingredient (API) or Danicopan finished formulations upon request. The Danicopan suppliers may include Danicopan API manufacturers, exporters, distributors and traders.
click here to find a list of Danicopan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 Danicopan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Danicopan API and other APIs are published in this directory by the FDA.
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 Danicopan 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.
The NDC directory also contains data on finished compounded human drug products that contain Danicopan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Danicopan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Danicopan suppliers with NDC on PharmaCompass.
Danicopan 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 Danicopan 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 Danicopan GMP manufacturer or Danicopan GMP API supplier for your needs.
A Danicopan CoA (Certificate of Analysis) is a formal document that attests to Danicopan's compliance with Danicopan specifications and serves as a tool for batch-level quality control.
Danicopan CoA mostly includes findings from lab analyses of a specific batch. For each Danicopan 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.
Danicopan may be tested according to a variety of international standards, such as European Pharmacopoeia (Danicopan EP), Danicopan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Danicopan USP).
