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Chemistry

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Also known as: Tak-438, 1260141-27-2, 881681-01-2, Vonoprazan fumurate, 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine fumarate, Tak 438
Molecular Formula
C21H20FN3O6S
Molecular Weight
461.5  g/mol
InChI Key
ROGSHYHKHPCCJW-WLHGVMLRSA-N
FDA UNII
4QW3X4AMLB

Vonoprazan Fumarate
Vonoprazan Fumarate is the fumarate salt form of vonoprazan, a pyrrole derivative and reversible potassium-competitive acid blocker (P-CAB), with potential antacid activity. Upon administration, vonoprazan specifically and competitively binds to the gastric hydrogen-potassium ATPase (H+/K+ ATPase) proton pump at or, more likely, near its potassium ion (K+) binding site and sterically inhibits K+ binding. This blocks the activation of the H+/K+ ATPase by K+, inhibits the proton pump and prevents gastric acid secretion, thereby lowering gastric acid levels.
1 2D Structure

Vonoprazan Fumarate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioic acid;1-[5-(2-fluorophenyl)-1-pyridin-3-ylsulfonylpyrrol-3-yl]-N-methylmethanamine
2.1.2 InChI
InChI=1S/C17H16FN3O2S.C4H4O4/c1-19-10-13-9-17(15-6-2-3-7-16(15)18)21(12-13)24(22,23)14-5-4-8-20-11-14;5-3(6)1-2-4(7)8/h2-9,11-12,19H,10H2,1H3;1-2H,(H,5,6)(H,7,8)/b;2-1+
2.1.3 InChI Key
ROGSHYHKHPCCJW-WLHGVMLRSA-N
2.1.4 Canonical SMILES
CNCC1=CN(C(=C1)C2=CC=CC=C2F)S(=O)(=O)C3=CN=CC=C3.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CNCC1=CN(C(=C1)C2=CC=CC=C2F)S(=O)(=O)C3=CN=CC=C3.C(=C/C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
4QW3X4AMLB
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine

2. Tak 438

3. Tak-438

4. Tak438

5. Vonoprazan

2.3.2 Depositor-Supplied Synonyms

1. Tak-438

2. 1260141-27-2

3. 881681-01-2

4. Vonoprazan Fumurate

5. 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine Fumarate

6. Tak 438

7. Tak-438 Monofumarate

8. Vonoprazan Monofumarate

9. Vonoprazan Fumarate (tak-438)

10. 4qw3x4amlb

11. Tak438

12. Unii-4qw3x4amlb

13. Takecab

14. Vocinti

15. (e)-but-2-enedioic Acid;1-[5-(2-fluorophenyl)-1-pyridin-3-ylsulfonylpyrrol-3-yl]-n-methylmethanamine

16. 1h-pyrrole-3-methanamine, 5-(2-fluorophenyl)-n-methyl-1-(3-pyridinylsulfonyl)-, (2e)-2-butenedioate (1:1)

17. 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine Xfumarate

18. 1h-pyrrole-3-methanamine, 5-(2-fluorophenyl)-n-methyl-1-(3-pyridinylsulfonyl)-, 2-butenedioate (1:1)

19. Mfcd18633280

20. Vonoprazan Monofumurate

21. 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl]-n-methylmethanamine Fumarate

22. Takecab (tn)

23. Vonoprazan Fumarate [usan]

24. Schembl194394

25. Schembl194396

26. Chembl2064032

27. Vonoprazan Fumarate [mi]

28. Vonoprazan Fumarate (jan/usan)

29. Ex-a097

30. Vonoprazan Fumarate [jan]

31. Bcp05635

32. Bcp13238

33. Ex-a4001

34. S8016

35. Vonoprazan Fumarate [who-dd]

36. Akos027251052

37. Ccg-269350

38. 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine Monofumarate

39. 5-(2-fluorophenyl)-n-methyl-1-(3-pyridinylsulfonyl)-1h-pyrrole-3-methanamine (2e)-2-butenedioate

40. Ac-29287

41. Ac-29309

42. Ds-12234

43. Ls-14849

44. Cs-0164592

45. Sw220126-1

46. D10466

47. A854789

48. A900258

49. J-524312

50. Q25104163

51. Tak438 Fumarate;tak-438 Fumarate;tak 438 Fumarate;1260141-27-2

52. 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine Fumarate? (vonoprazan Impurity Pound(c)

53. 2098974-13-9

54. 5-(2-fluorophenyl)-n-methyl-1-(3-pyridinylsulfonyl)-1h-pyrrole-3-methanamine 2-butenedioate

2.4 Create Date
2010-05-17
3 Chemical and Physical Properties
Molecular Weight 461.5 g/mol
Molecular Formula C21H20FN3O6S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count9
Rotatable Bond Count7
Exact Mass461.10568470 g/mol
Monoisotopic Mass461.10568470 g/mol
Topological Polar Surface Area147 Ų
Heavy Atom Count32
Formal Charge0
Complexity629
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API Reference Price

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OF","quantity":"0.40","actualQuantity":"400","unit":"GMS","unitRateFc":"1.3","totalValueFC":"432.2","currency":"USD","unitRateINR":94.555575000000005,"date":"02-Aug-2025","totalValueINR":"37822.23","totalValueInUsd":"432.2","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4108113","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"MNO 628 401 GNO AT URAWADE,TALUKA, PUNE,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1755628200,"product":"VONOPRAZAN FUMARATE","address":"2 FLR.PRESTIGE PLAZA","city":"AKOTA BARODA","supplier":"AMI LIFESCIENCES PVT LTD","supplierCountry":"INDIA","foreign_port":"JEDDAH","customer":"SAUDI ARABIA","customerCountry":"SAUDI ARABIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"500","totalValueFC":"29600.6","currency":"USD","unitRateINR":43177.2065,"date":"20-Aug-2025","totalValueINR":"2590632.39","totalValueInUsd":"29600.6","indian_port":"Ahmedabad Air","hs_no":"29333990","bill_no":"4579419","productDescription":"API","marketType":"","country":"SAUDI ARABIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"2 FLR.PRESTIGE PLAZA, AKOTA BARODA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1755801000,"product":"PHARMACEUTICAL RAW MATERIAL AS PER PO NO.HPI-250812-25 VONOPRAZAN FUMARATE","address":"2 FLR.PRESTIGE PLAZA","city":"AKOTA BARODA","supplier":"AMI LIFESCIENCES PVT LTD","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"UNDISCLOSED","customerCountry":"KOREA, REPUBLIC OF","quantity":"17.00","actualQuantity":"17","unit":"KGS","unitRateFc":"2000","totalValueFC":"33389.6","currency":"USD","unitRateINR":171896.74411764706,"date":"22-Aug-2025","totalValueINR":"2922244.65","totalValueInUsd":"33389.6","indian_port":"Ahmedabad Air","hs_no":"29333990","bill_no":"4646530","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"2 FLR.PRESTIGE PLAZA, AKOTA BARODA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1755801000,"product":"VONOPRAZAN FUMARATE B NO-VPI05-25002\/MMFG.DT.MAY 25 RETEST DT.APR.2028 B.NO-VPI05-25003 MFG.DT.AUG.25 RET.DT.JUL.28","address":"MOREPEN VILLAGE, NALAGARH ROAD,","city":"N\/A","supplier":"MOREPEN LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"UNDISCLOSED","customerCountry":"TURKEY","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"1800","totalValueFC":"21141.6","currency":"USD","unitRateINR":154192.33333333334,"date":"22-Aug-2025","totalValueINR":"1850308","totalValueInUsd":"21141.6","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"4640966","productDescription":"API","marketType":"","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"MOREPEN VILLAGE, NALAGARH ROAD,, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1755801000,"product":"VONOPRAZAN FUMARATE (TAX INVOICE NO: VTSIE2526000025 DT: 19\/08\/2025)","address":"PLOT NO 34 SY NO 30\/P 38\/P 39\/P,GA","city":"HYDERABAD,TELANGANA","supplier":"VIYASH LIFE SCIENCES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"TUNIS","customer":"ACT PHARMA","customerCountry":"TUNISIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1050","totalValueFC":"929.4","currency":"USD","unitRateINR":81343,"date":"22-Aug-2025","totalValueINR":"81343","totalValueInUsd":"929.4","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"4666133","productDescription":"API","marketType":"","country":"TUNISIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO 34 SY NO 30\/P 38\/P 39\/P,GA, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1755887400,"product":"VONOPRAZAN FUMARATE","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. AP","supplier":"OPTIMUS DRUGS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MONTEVIDEO -","customer":"UNDISCLOSED","customerCountry":"URUGUAY","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"1200","totalValueFC":"87833.9","currency":"USD","unitRateINR":102495.90666666666,"date":"23-Aug-2025","totalValueINR":"7687193","totalValueInUsd":"87833.9","indian_port":"Hyderabad Air","hs_no":"29420022","bill_no":"4695704","productDescription":"API","marketType":"","country":"URUGUAY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.131,3RD FLOOR,NARMADA, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1756146600,"product":"VONOPRAZAN FUMARATE, BATCH NO-VPH-PU\/25004, MFG DT-APR-2025, RETEST DT-MAR-2028","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BIRGUNJ","customer":"MAGNUS PHARMA PVT LTD","customerCountry":"NEPAL","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"35000","totalValueFC":"3999.1","currency":"N\/A","unitRateINR":35000,"date":"26-Aug-2025","totalValueINR":"350000","totalValueInUsd":"3999.1","indian_port":"Raxaul","hs_no":"29420090","bill_no":"4767577","productDescription":"API","marketType":"","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Raxaul","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1756319400,"product":"VONOPRAZAN FUMARATE","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"SINGAPORE","customer":"VARTIA PHARMA PTE LTD.","customerCountry":"SINGAPORE","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"910","totalValueFC":"67005.7","currency":"USD","unitRateINR":78190.933333333334,"date":"28-Aug-2025","totalValueINR":"5864320","totalValueInUsd":"67005.7","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4805773","productDescription":"API","marketType":"","country":"SINGAPORE","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1673807400,"product":"VONOPRAZAN FUMARATE","address":"811 THE SUMMIT BUSINESS BAY, NR W E,HIGHWAY METRO STATION, ANDHERI KU","city":"MUMBAI,MAHARASHTRA","supplier":"ZHEJIANG RUILIAN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"MEHTA API PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1500","totalValueFC":"1535.6","currency":"USD","unitRateINR":"125550","date":"16-Jan-2023","totalValueINR":"125550","totalValueInUsd":"1535.6","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"4201734","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"811 THE SUMMIT BUSINESS BAY, NR W E,HIGHWAY METRO STATION, ANDHERI KU"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695234600,"product":"VONOPRAZAN FUMARATE","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"SHANDONG LONCOM PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2700","totalValueFC":"2730.6","currency":"USD","unitRateINR":"226665","date":"21-Sep-2023","totalValueINR":"226665","totalValueInUsd":"2730.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"7925496","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"ADD: NO. 127, QIZHONG AVENUE, QIHECOUNTRY, DEZHOU, SHANDONG P.R. CHINA. China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"}]
25-Jan-2022
28-Aug-2025
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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Drugs in Development

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Details:

Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.


Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Voquezna Triple Pack

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Phathom Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 24, 2022

Evonik company banner

01

Evonik

Germany
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Lead Product(s) : Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Phathom Pharmaceuticals

Deal Size : Undisclosed

Deal Type : Agreement

Details : Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.

Product Name : Voquezna Triple Pack

Product Type : Miscellaneous

Upfront Cash : Undisclosed

October 24, 2022

Evonik company banner

Details:

Voquezna (vonoprazan) is a potassium-competitive acid blocker, indicated for heartburn associated with Non-Erosive GERD.


Lead Product(s): Vonoprazan Fumarate,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Voquezna

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 06, 2025

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Details : Voquezna (vonoprazan) is a potassium-competitive acid blocker, indicated for heartburn associated with Non-Erosive GERD.

Product Name : Voquezna

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 06, 2025

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Details:

Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Eosinophilic Esophagitis.


Lead Product(s): Vonoprazan Fumarate,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 28, 2025

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Not Confirmed
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Not Confirmed

Details : Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Eosinophilic Esophagitis.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 28, 2025

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Details:

Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Vonoprazan Fumarate,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 18, 2025

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Not Confirmed
PREP
Not Confirmed

Details : Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 18, 2025

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Details:

Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Stomach Ulcer.


Lead Product(s): Vonoprazan Fumarate,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 15, 2024

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PREP
Not Confirmed

Details : Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Stomach Ulcer.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 15, 2024

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Details:

Under the terms of this agreement, Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Lupivon (vonoprazan), a novel potassium-competitive acid blocker, in India.


Lead Product(s): Vonoprazan Fumarate,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Lupivon

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Lupin Ltd

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement September 18, 2024

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Details : Under the terms of this agreement, Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Lupivon (vonoprazan), a novel potassium-competitive acid blocker, in India.

Product Name : Lupivon

Product Type : Miscellaneous

Upfront Cash : Undisclosed

September 18, 2024

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Details:

The licensing deal will enhance Alkem's offerings in the gastrointestinal segment by including Vonzai (vonoprazan), a first-in-class potassium-competitive acid blocker.


Lead Product(s): Vonoprazan Fumarate,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Vonzai

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Alkem Laboratories

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement September 03, 2024

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Details : The licensing deal will enhance Alkem's offerings in the gastrointestinal segment by including Vonzai (vonoprazan), a first-in-class potassium-competitive acid blocker.

Product Name : Vonzai

Product Type : Miscellaneous

Upfront Cash : Undisclosed

September 03, 2024

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Details:

Phathom intends to use the net proceeds from the offering to fund commercialization expenses and further clinical development of Voquezna (vonoprazan) for the treatment of Erosive GERD.


Lead Product(s): Vonoprazan Fumarate,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Voquezna

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Evercore ISI

Deal Size: $130.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering August 19, 2024

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Details : Phathom intends to use the net proceeds from the offering to fund commercialization expenses and further clinical development of Voquezna (vonoprazan) for the treatment of Erosive GERD.

Product Name : Voquezna

Product Type : Miscellaneous

Upfront Cash : Undisclosed

August 19, 2024

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Details:

Under the terms of this agreement, Takeda has granted Zydus non-exclusive patent licensing rights for the commercialization of Vault (vonoprazan) in India.


Lead Product(s): Vonoprazan Fumarate,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Vault

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Zydus Lifesciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 19, 2024

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Not Confirmed

Details : Under the terms of this agreement, Takeda has granted Zydus non-exclusive patent licensing rights for the commercialization of Vault (vonoprazan) in India.

Product Name : Vault

Product Type : Miscellaneous

Upfront Cash : Undisclosed

July 19, 2024

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Details:

Under the terms of this agreement, Takeda has granted Reddy non-exclusive patent licensing rights for the commercialization of Voquezna (vonoprazan) in India.


Lead Product(s): Vonoprazan Fumarate,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Vault

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Dr. Reddy\'s Laboratories

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 18, 2024

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Details : Under the terms of this agreement, Takeda has granted Reddy non-exclusive patent licensing rights for the commercialization of Voquezna (vonoprazan) in India.

Product Name : Vault

Product Type : Miscellaneous

Upfront Cash : Undisclosed

July 18, 2024

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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 1240948-77-9

End Use API : Vonoprazan Fumarate

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...

Shandong Chenghui Shuangda Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 881674-56-2

End Use API : Vonoprazan Fumarate

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...

Shandong Chenghui Shuangda Pharmaceutical

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 16133-25-8

End Use API : Vonoprazan Fumarate

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...

Shandong Chenghui Shuangda Pharmaceutical

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

CAS Number : 16133-25-8

End Use API : Vonoprazan Fumarate

About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

Jinan Tantu Chemicals

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

CAS Number : 881674-56-2

End Use API : Vonoprazan Fumarate

About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...

Shandong Loncom Pharmaceutical company banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

CAS Number : 16133-25-8

End Use API : Vonoprazan Fumarate

About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...

Shandong Loncom Pharmaceutical company banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

CAS Number : 807-719-6

End Use API : Vonoprazan Fumarate

About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...

Shandong Loncom Pharmaceutical company banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 16133-25-8

End Use API : Vonoprazan Fumarate

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 881674-56-2

End Use API : Vonoprazan Fumarate

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

CAS Number : 881674-56-2

End Use API : Vonoprazan Fumarate

About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...

Tagoor Laboratories
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FDF Dossiers

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01

PREP
Not Confirmed
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PREP
Not Confirmed

Vonoprazan

Brand Name : Vonacidan

Dosage Form : Film-Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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Not Confirmed
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Vonoprazan

Brand Name : Vonacidan

Dosage Form : Film-Coated Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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EP Pharma

Egypt
PREP
Not Confirmed
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EP Pharma

Egypt
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PREP
Not Confirmed

Vonoprazan

Brand Name : Arromaprazan

Dosage Form : FC Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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EP Pharma

Egypt
PREP
Not Confirmed
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EP Pharma

Egypt
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PREP
Not Confirmed

Vonoprazan

Brand Name : Arromaprazan

Dosage Form : FC Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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Vonoprazan

Brand Name : Leurovendin

Dosage Form : Film Coated Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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Not Confirmed
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VONOPRAZAN FUMARATE

Brand Name : VOQUEZNA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2023-11-01

Application Number : 215151

Regulatory Info : RX

Registration Country : USA

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PREP
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US Patent Number : 9186411

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 215151

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-08-11

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US Patent Number : 7977488

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Application Number : 215151

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Patent Use Description :

Patent Expiration Date : 2028-08-11

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US Patent Number : 7977488

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Application Number : 215151

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Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-08-11

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US Patent Number : 9186411

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Drug Product Claim : Y

Application Number : 215151

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-08-11

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Exclusivity Code : I-948

Exclusivity Expiration Date : 2027-07-17

Application Number : 215151

Product Number : 1

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Exclusivity Code : NCE

Exclusivity Expiration Date : 2027-05-03

Application Number : 215151

Product Number : 1

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Exclusivity Code : NP

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Application Number : 215151

Product Number : 1

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Exclusivity Code : NCE

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Product Number : 2

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Exclusivity Code : NP

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Product Number : 2

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Exclusivity Code : GAIN

Exclusivity Expiration Date : 2032-05-03

Application Number : 215151

Product Number : 1

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Exclusivity Code : GAIN

Exclusivity Expiration Date : 2032-05-03

Application Number : 215151

Product Number : 2

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ABOUT THIS PAGE

Looking for 1260141-27-2 / Vonoprazan Fumarate API manufacturers, exporters & distributors?

Vonoprazan Fumarate manufacturers, exporters & distributors 1

36

PharmaCompass offers a list of Vonoprazan Fumarate 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 Vonoprazan Fumarate manufacturer or Vonoprazan Fumarate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vonoprazan Fumarate manufacturer or Vonoprazan Fumarate supplier.

PharmaCompass also assists you with knowing the Vonoprazan Fumarate API Price utilized in the formulation of products. Vonoprazan Fumarate API Price is not always fixed or binding as the Vonoprazan Fumarate Price is obtained through a variety of data sources. The Vonoprazan Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Vonoprazan Fumarate

Synonyms

Tak-438, 1260141-27-2, 881681-01-2, Vonoprazan fumurate, 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine fumarate, Tak 438

Cas Number

1260141-27-2

Unique Ingredient Identifier (UNII)

4QW3X4AMLB

About Vonoprazan Fumarate

Vonoprazan Fumarate is the fumarate salt form of vonoprazan, a pyrrole derivative and reversible potassium-competitive acid blocker (P-CAB), with potential antacid activity. Upon administration, vonoprazan specifically and competitively binds to the gastric hydrogen-potassium ATPase (H+/K+ ATPase) proton pump at or, more likely, near its potassium ion (K+) binding site and sterically inhibits K+ binding. This blocks the activation of the H+/K+ ATPase by K+, inhibits the proton pump and prevents gastric acid secretion, thereby lowering gastric acid levels.

Vonoprazan Fumarate Manufacturers

A Vonoprazan Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vonoprazan Fumarate, including repackagers and relabelers. The FDA regulates Vonoprazan Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vonoprazan Fumarate 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 Vonoprazan Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Vonoprazan Fumarate Suppliers

A Vonoprazan Fumarate supplier is an individual or a company that provides Vonoprazan Fumarate active pharmaceutical ingredient (API) or Vonoprazan Fumarate finished formulations upon request. The Vonoprazan Fumarate suppliers may include Vonoprazan Fumarate API manufacturers, exporters, distributors and traders.

click here to find a list of Vonoprazan Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Vonoprazan Fumarate USDMF

A Vonoprazan Fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Vonoprazan Fumarate active pharmaceutical ingredient (API) in detail. Different forms of Vonoprazan Fumarate DMFs exist exist since differing nations have different regulations, such as Vonoprazan Fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Vonoprazan Fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Vonoprazan Fumarate USDMF includes data on Vonoprazan Fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vonoprazan Fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Vonoprazan Fumarate suppliers with USDMF on PharmaCompass.

Vonoprazan Fumarate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Vonoprazan Fumarate Drug Master File in Korea (Vonoprazan Fumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vonoprazan Fumarate. The MFDS reviews the Vonoprazan Fumarate KDMF as part of the drug registration process and uses the information provided in the Vonoprazan Fumarate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Vonoprazan Fumarate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Vonoprazan Fumarate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Vonoprazan Fumarate suppliers with KDMF on PharmaCompass.

Vonoprazan Fumarate WC

A Vonoprazan Fumarate written confirmation (Vonoprazan Fumarate WC) is an official document issued by a regulatory agency to a Vonoprazan Fumarate manufacturer, verifying that the manufacturing facility of a Vonoprazan Fumarate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vonoprazan Fumarate APIs or Vonoprazan Fumarate finished pharmaceutical products to another nation, regulatory agencies frequently require a Vonoprazan Fumarate WC (written confirmation) as part of the regulatory process.

click here to find a list of Vonoprazan Fumarate suppliers with Written Confirmation (WC) on PharmaCompass.

Vonoprazan Fumarate NDC

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 Vonoprazan Fumarate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Vonoprazan Fumarate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Vonoprazan Fumarate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Vonoprazan Fumarate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vonoprazan Fumarate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Vonoprazan Fumarate suppliers with NDC on PharmaCompass.

Vonoprazan Fumarate GMP

Vonoprazan Fumarate 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 Vonoprazan Fumarate 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 Vonoprazan Fumarate GMP manufacturer or Vonoprazan Fumarate GMP API supplier for your needs.

Vonoprazan Fumarate CoA

A Vonoprazan Fumarate CoA (Certificate of Analysis) is a formal document that attests to Vonoprazan Fumarate's compliance with Vonoprazan Fumarate specifications and serves as a tool for batch-level quality control.

Vonoprazan Fumarate CoA mostly includes findings from lab analyses of a specific batch. For each Vonoprazan Fumarate 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.

Vonoprazan Fumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Vonoprazan Fumarate EP), Vonoprazan Fumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vonoprazan Fumarate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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