Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Europe
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South Africa
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1. 3-(((1s,2s,3r)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1h-inden-4-yl)oxy)-5-fluorobenzonitrile
2. Mk-6482
3. Mk6482
4. Pt-2977
5. Pt2977
6. Welireg
1. Pt2977
2. 1672668-24-4
3. Mk-6482
4. Welireg
5. Mk6482
6. Belzutifan [inn]
7. Belzutifan [usan]
8. Pt-2977
9. 3-(((1s,2s,3r)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1h-inden-4-yl)oxy)-5-fluorobenzonitrile
10. 7k28nb895l
11. 3-[[(1s,2s,3r)-2,3-difluoro-1-hydroxy-7-methylsulfonyl-2,3-dihydro-1h-inden-4-yl]oxy]-5-fluorobenzonitrile
12. 3-{[(1s,2s,3r)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1h-inden-4-yl]oxy}-5-fluorobenzonitrile
13. 3-((1s,2s,3r)-2,3-difluoro-1-hydroxy-7-methylsulfonylindan-4-yl)oxy-5-fluoro-benzonitrile
14. Benzonitrile, 3-(((1s,2s,3r)-2,3-difluoro-2,3-dihydro-1-hydroxy-7-(methylsulfonyl)-1h-inden-4-yl)oxy)-5-fluoro-
15. Belzutifan [who-dd]
16. Unii-7k28nb895l
17. Belzutifan [orange Book]
18. Chembl4585668
19. Schembl16560918
20. Gtpl11251
21. Pt 2977 [who-dd]
22. Bdbm373040
23. Dtxsid201334517
24. Pt 2977
25. Ex-a4441
26. Us9896418, Compound 289
27. Xrc66824
28. Nsc825217
29. Who 11196
30. At14994
31. Belzutifan (pt2977, Mk-6482)
32. Compound 2 [pmid: 31282155]
33. Nsc-825217
34. Mk-6482; Pt2977
35. Ac-35183
36. Hy-125840
37. Cs-0101119
38. A935088
39. Q27456641
40. 3-(((1s,2s,3r)-2,3-difluoro-1-hydroxy-7-(methanesulfonyl)-2,3-dihydro-1h-inden-4-yl)oxy)-5-fluorobenzonitrile
41. 3-((1s,2s,3r)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1h-inden-4-yloxy)-5-fluorobenzonitrile
42. 72q
Molecular Weight | 383.3 g/mol |
---|---|
Molecular Formula | C17H12F3NO4S |
XLogP3 | 2 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 3 |
Exact Mass | 383.04391352 g/mol |
Monoisotopic Mass | 383.04391352 g/mol |
Topological Polar Surface Area | 95.8 Ų |
Heavy Atom Count | 26 |
Formal Charge | 0 |
Complexity | 675 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Belzutifan is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), who do not require immediate surgery.
Belzutifan exerts its therapeutic effects by inhibiting a transcription factor necessary for the growth of solid tumors associated with VHL disease. It is taken once daily at approximately the same time each day, with or without food. Both severe anemia and hypoxia have been observed following therapy with belzutifan, and patients should be monitored closely before and during therapy to ensure patients can be managed as clinically indicated. There are no data regarding the use of erythropoiesis-stimulating agents for the treatment of belzutifan-induced anemia, and as such these therapies should be avoided. Belzutifan may cause embryo-fetal toxicity when administered to pregnant women. Female patients and male patients with female partners of reproductive potential should ensure that an effective form of contraception is used throughout therapy and for one week after the last dose - as belzutifan appears to decrease the efficacy of systemic hormonal contraceptives, patients should be advised to use an additional method of contraception (e.g. condoms) to eliminate the possibility of pregnancy during therapy.
Antineoplastic Agents
Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01X - Other antineoplastic agents
L01XX - Other antineoplastic agents
L01XX74 - Belzutifan
Absorption
In patients with VHL disease-associated renal cell carcinoma, the mean Cmax and AUC0-24h at steady-state - which was achieved after approximately three days of therapy - were 1.3 g/mL and 16.7 ghr/mL, respectively. The median Tmax is one to two hours following oral administration. The administration of belzutifan with food has a negligible effect on drug disposition - when given alongside a high-calorie, high-fat meal, the Tmax was delayed by approximately 2 hours with no other clinically meaningful effects observed.
Volume of Distribution
The steady-state volume of distribution of belzutifan following oral administration is approximately 130 L.
Clearance
The mean clearance of belzutifan following oral administration is 7.3 L/h.
Belzutifan is primarily metabolized by UGT2B17 and CYP2C19, and to a lesser extent by CYP3A4.
The mean elimination half-life of belzutifan is 14 hours.
Hypoxia-inducible factor 2 (HIF-2) is a transcription factor which aids in oxygen sensing by regulating genes that promote adaptation to hypoxia. In healthy patients, when oxygen levels are normal, HIF-2 is broken down via ubiquitin-proteasomal degradation by von-Hippel Lindau (VHL) proteins. In the presence of hypoxia, HIF-2 translocates into cell nuclei and forms a transcriptional complex with hypoxia-inducible factor 1 (HIF-1) - this complex then induces the expression of downstream genes associated with cellular proliferation and angiogenesis. Patients with von-Hippel Lindau (VHL) disease lack functional VHL proteins, leading to an accumulation of HIF-2, and this accumulation is what drives the growth of VHL-associated tumors. Belzutifan is an inhibitor of HIF-2 that prevents its complexation with HIF-1 in conditions of hypoxia or impaired VHL protein function, thereby reducing the expression of HIF-2 target genes and slowing/stopping the growth of VHL-associated tumors.
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Details:
Welireg (belzutifan) is first and only HIF-2α inhibitor, being investigated for the treatment of 12 years and older with advanced, unresectable pheochromocytoma and paraganglioma (PPGL).
Lead Product(s): Belzutifan
Therapeutic Area: Oncology Brand Name: Welireg
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 14, 2025
Lead Product(s) : Belzutifan
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Clears Merck’s WELIREG for Adults and Teens with Advanced PPGL
Details : Welireg (belzutifan) is first and only HIF-2α inhibitor, being investigated for the treatment of 12 years and older with advanced, unresectable pheochromocytoma and paraganglioma (PPGL).
Product Name : Welireg
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 14, 2025
Details:
Welireg (belzutifan), an oral HIF-2α inhibitor, being evaluated for the treatment of adult and pediatric patients with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
Lead Product(s): Belzutifan
Therapeutic Area: Rare Diseases and Disorders Brand Name: Welireg
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 18, 2025
Lead Product(s) : Belzutifan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications
Details : Welireg (belzutifan), an oral HIF-2α inhibitor, being evaluated for the treatment of adult and pediatric patients with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
Product Name : Welireg
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 18, 2025
Details:
Welireg (belzutifan), an oral HIF-2α inhibitor, being evaluated for the treatment of adult and pediatric patients with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
Lead Product(s): Belzutifan
Therapeutic Area: Oncology Brand Name: Welireg
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 27, 2025
Lead Product(s) : Belzutifan
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Grants Priority Review to Merck’s Welireg for Advanced PPGL
Details : Welireg (belzutifan), an oral HIF-2α inhibitor, being evaluated for the treatment of adult and pediatric patients with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
Product Name : Welireg
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 27, 2025
Details:
Welireg (belzutifan) is first and only HIF-2α inhibitor, being investigated for the treatment of 12 years and older with advanced, unresectable pheochromocytoma and paraganglioma (PPGL).
Lead Product(s): Belzutifan
Therapeutic Area: Oncology Brand Name: Welireg
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 27, 2025
Lead Product(s) : Belzutifan
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Grants Priority Review to Merck’s Welireg for PPGL Treatment
Details : Welireg (belzutifan) is first and only HIF-2α inhibitor, being investigated for the treatment of 12 years and older with advanced, unresectable pheochromocytoma and paraganglioma (PPGL).
Product Name : Welireg
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 27, 2025
Details:
Welireg (belzutifan) is first and only hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor approved for the adult patients with advanced renal cell carcinoma (RCC).
Lead Product(s): Belzutifan
Therapeutic Area: Rare Diseases and Disorders Brand Name: Welireg
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 13, 2024
Lead Product(s) : Belzutifan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Merck Receives EU CHMP Opinion for WELIREG® Treatment of VHL Disease, RCC Tumors
Details : Welireg (belzutifan) is first and only hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor approved for the adult patients with advanced renal cell carcinoma (RCC).
Product Name : Welireg
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 13, 2024
Details:
HC-7366, a selective activator of general control nonderepressible 2 kinases, is under investigation with Welireg for clear cell renal cell carcinoma treatment.
Lead Product(s): HC-7366,Belzutifan
Therapeutic Area: Oncology Brand Name: HC-7366
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 05, 2024
Lead Product(s) : HC-7366,Belzutifan
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
HiberCell Doses First Patient in Merck Collaboration for Advanced ccRCC
Details : HC-7366, a selective activator of general control nonderepressible 2 kinases, is under investigation with Welireg for clear cell renal cell carcinoma treatment.
Product Name : HC-7366
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 05, 2024
Details:
Welireg (belzutifan) is first and only hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor approved for the adult patients with advanced renal cell carcinoma (RCC).
Lead Product(s): Belzutifan
Therapeutic Area: Oncology Brand Name: Welireg
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 14, 2023
Lead Product(s) : Belzutifan
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Ce...
Details : Welireg (belzutifan) is first and only hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor approved for the adult patients with advanced renal cell carcinoma (RCC).
Product Name : Welireg
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 14, 2023
Details:
Welireg (belzutifan) 40 mg tablet act as the HIF-2α inhibitor, which is investigated for the treatment of adult patients with advanced renal cell carcinoma.
Lead Product(s): Belzutifan
Therapeutic Area: Oncology Brand Name: Welireg
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 19, 2023
Lead Product(s) : Belzutifan
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for WELIREG® (belzuti...
Details : Welireg (belzutifan) 40 mg tablet act as the HIF-2α inhibitor, which is investigated for the treatment of adult patients with advanced renal cell carcinoma.
Product Name : Welireg
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 19, 2023
Details:
WELIREG (belzutifan) 40 mg tablet act as the HIF-2α inhibitor, which is investigated for the treatment of adult patients with advanced renal cell carcinoma
Lead Product(s): Belzutifan
Therapeutic Area: Oncology Brand Name: Welireg
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 18, 2023
Lead Product(s) : Belzutifan
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Merck Announces WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of Progres...
Details : WELIREG (belzutifan) 40 mg tablet act as the HIF-2α inhibitor, which is investigated for the treatment of adult patients with advanced renal cell carcinoma
Product Name : Welireg
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 18, 2023
Details:
The collaboration aims to evaluate HiberCell's HC-7366, a selective activator of the general control nonderepressible 2 kinases in combination with Welireg (belzutifan), Merck’s oral HIF-2α inhibitor for the treatment of clear cell renal cell carcinoma.
Lead Product(s): HC-7366,Belzutifan
Therapeutic Area: Oncology Brand Name: HC-7366
Study Phase: PreclinicalProduct Type: Other Small Molecule
Sponsor: Merck & Co
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 12, 2023
Lead Product(s) : HC-7366,Belzutifan
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Undisclosed
Deal Type : Collaboration
Details : The collaboration aims to evaluate HiberCell's HC-7366, a selective activator of the general control nonderepressible 2 kinases in combination with Welireg (belzutifan), Merck’s oral HIF-2α inhibitor for the treatment of clear cell renal cell carcinom...
Product Name : HC-7366
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
May 12, 2023
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PharmaCompass offers a list of Belzutifan 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 Belzutifan manufacturer or Belzutifan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Belzutifan manufacturer or Belzutifan supplier.
PharmaCompass also assists you with knowing the Belzutifan API Price utilized in the formulation of products. Belzutifan API Price is not always fixed or binding as the Belzutifan Price is obtained through a variety of data sources. The Belzutifan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Belzutifan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Belzutifan, including repackagers and relabelers. The FDA regulates Belzutifan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Belzutifan 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 Belzutifan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Belzutifan supplier is an individual or a company that provides Belzutifan active pharmaceutical ingredient (API) or Belzutifan finished formulations upon request. The Belzutifan suppliers may include Belzutifan API manufacturers, exporters, distributors and traders.
click here to find a list of Belzutifan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Belzutifan DMF (Drug Master File) is a document detailing the whole manufacturing process of Belzutifan active pharmaceutical ingredient (API) in detail. Different forms of Belzutifan DMFs exist exist since differing nations have different regulations, such as Belzutifan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Belzutifan DMF submitted to regulatory agencies in the US is known as a USDMF. Belzutifan USDMF includes data on Belzutifan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Belzutifan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Belzutifan suppliers with USDMF 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 Belzutifan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Belzutifan 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 Belzutifan 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 Belzutifan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Belzutifan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Belzutifan suppliers with NDC on PharmaCompass.
Belzutifan 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 Belzutifan 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 Belzutifan GMP manufacturer or Belzutifan GMP API supplier for your needs.
A Belzutifan CoA (Certificate of Analysis) is a formal document that attests to Belzutifan's compliance with Belzutifan specifications and serves as a tool for batch-level quality control.
Belzutifan CoA mostly includes findings from lab analyses of a specific batch. For each Belzutifan 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.
Belzutifan may be tested according to a variety of international standards, such as European Pharmacopoeia (Belzutifan EP), Belzutifan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Belzutifan USP).