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Also known as: 1350653-20-1, Verquvo, Methyl (4,6-diamino-2-(5-fluoro-1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl)pyrimidin-5-yl)carbamate, Mk-1242, Vericiguat [inn], Bay-1021189
Molecular Formula
C19H16F2N8O2
Molecular Weight
426.4  g/mol
InChI Key
QZFHIXARHDBPBY-UHFFFAOYSA-N
FDA UNII
LV66ADM269

Vericiguat
Vericiguat is a direct stimulator of soluble guanylate cyclase (sGC) used in the management of systolic heart failure to reduce mortality and hospitalizations. A key component of the NO-sGC-cGMP signaling pathway that helps to regulate the cardiovascular system, sGC enzymes are intracellular enzymes found in vascular smooth muscle cells (amongst other cell types) that catalyze the synthesis of cyclic guanosine monophosphate (cGMP) in response to activation by nitric oxide (NO). Cyclic GMP acts as a second messenger, activating a number of downstream signaling cascades that elicit a broad variety of effects, and these diverse cellular effects have implicated deficiencies in its production (primarily due to insufficient NO bioavailability) in the pathogenesis of various cardiovascular diseases. As a direct stimulator of sGC, vericiguat mitigates the need for a functional NO-sGC-cGMP axis and thereby helps to prevent the myocardial and vascular dysfunction associated with decreased sGC activity in heart failure. Vericiguat was approved by the FDA in January 2021 - developed by Merck under the brand name Verquvo - for use in certain patients with systolic heart failure. Although not the first sGC stimulator to be granted FDA approval ([riociguat] was approved in 2013 for use in pulmonary hypertension), vericiguat is unique amongst its peers in that modifications to its structure have dramatically decreased its susceptibility to oxidative metabolism, resulting in a relatively long half-life and allowing for once-daily dosing.
Vericiguat is a Soluble Guanylate Cyclase Stimulator. The mechanism of action of vericiguat is as a Guanylate Cyclase Stimulator.
1 2D Structure

Vericiguat

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
methyl N-[4,6-diamino-2-[5-fluoro-1-[(2-fluorophenyl)methyl]pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]carbamate
2.1.2 InChI
InChI=1S/C19H16F2N8O2/c1-31-19(30)25-14-15(22)26-17(27-16(14)23)13-11-6-10(20)7-24-18(11)29(28-13)8-9-4-2-3-5-12(9)21/h2-7H,8H2,1H3,(H,25,30)(H4,22,23,26,27)
2.1.3 InChI Key
QZFHIXARHDBPBY-UHFFFAOYSA-N
2.1.4 Canonical SMILES
COC(=O)NC1=C(N=C(N=C1N)C2=NN(C3=C2C=C(C=N3)F)CC4=CC=CC=C4F)N
2.2 Other Identifiers
2.2.1 UNII
LV66ADM269
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Bay 1021189

2. Verquvo

2.3.2 Depositor-Supplied Synonyms

1. 1350653-20-1

2. Verquvo

3. Methyl (4,6-diamino-2-(5-fluoro-1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl)pyrimidin-5-yl)carbamate

4. Mk-1242

5. Vericiguat [inn]

6. Bay-1021189

7. Bay 1021189

8. Vericiguat [usan]

9. Bay1021189

10. Lv66adm269

11. Methyl N-[4,6-diamino-2-[5-fluoro-1-[(2-fluorophenyl)methyl]pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]carbamate

12. Methyl (4,6-diamino-2-(5-fluoro-1-((2-fluorophenyl)methyl)-1h-pyrazolo(3,4-b)pyridin-3-yl(pyrimidin-5-yl)carbamate

13. Methyl (4,6-diamino-2-(5-fluoro-1-(2-fluorobenzyl)-1h-pyrazolo(3,4-b)pyridin-3-yl)pyrimidin-5-yl)carbamate

14. Methyl N-(4,6-diamino-2-(5-fluoro-1-(2-fluorobenzyl)-1h-pyrazolo(3,4-b)pyridin-3-yl)pyrimidin-5-yl)carbamate

15. Unii-lv66adm269

16. Methyl {4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}carbamate

17. Vericiguatum

18. Vericiguat [jan]

19. Vericiguat [usan:inn]

20. Vericiguat [who-dd]

21. Bay1021189; Verquvo

22. Schembl429958

23. Vericiguat (jan/usan/inn)

24. Chembl4066936

25. Vericiguat [orange Book]

26. Gtpl10010

27. Chebi:142432

28. Dtxsid001318361

29. Bcp18886

30. Ex-a4694

31. Who 9805

32. Mfcd28502029

33. S9693

34. Zinc72318626

35. Cs-6981

36. Db15456

37. Sb16806

38. Ac-36737

39. Hy-16774

40. Bay1021189bay1021189

41. J3.590.750e

42. D11051

43. P14957

44. A887763

45. Q27283201

46. Bay1021189; Bay 1021189; Bay-1021189; Bay10-21189; Bay-10-21189; Bay 10-21189

47. Methyl 4,6-diamino-2-(5-fluoro-1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl)pyrimidin-5-ylcarbamate

48. Methyl{4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}carbamate

2.4 Create Date
2011-12-26
3 Chemical and Physical Properties
Molecular Weight 426.4 g/mol
Molecular Formula C19H16F2N8O2
XLogP31.5
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count10
Rotatable Bond Count5
Exact Mass426.13642811 g/mol
Monoisotopic Mass426.13642811 g/mol
Topological Polar Surface Area147 Ų
Heavy Atom Count31
Formal Charge0
Complexity622
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Vericiguat is indicated in adults with symptomatic, chronic heart failure and an ejection fraction of <45% to reduce the risk of cardiovascular death and heart failure-related hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics.


Treatment of symptomatic chronic heart failure


5 Pharmacology and Biochemistry
5.1 Pharmacology

By directly stimulating the increased production of intracellular cyclic guanosine monophosphate (cGMP), vericiguat causes the relaxation of vascular smooth muscle and vasodilation. Vericiguat has a relatively long half-life (~30h) that allows for once-daily dosing. Animal reproduction studies have demonstrated the potential for embryo-fetal toxicity when vericiguat is administered to pregnant females - defects in major vessel and heart formation, as well as spontaneous abortions/resorptions, were observed when vericiguat was administered to pregnant rabbits during organogenesis. The possibility of pregnancy should be excluded prior to beginning therapy with vericiguat, and adequate contraception should be used throughout therapy and for one month following cessation of treatment.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
VERICIGUAT
5.2.2 FDA UNII
LV66ADM269
5.2.3 Pharmacological Classes
Soluble Guanylate Cyclase Stimulator [EPC]; Guanylate Cyclase Stimulators [MoA]
5.3 ATC Code

C01


C - Cardiovascular system

C01 - Cardiac therapy

C01D - Vasodilators used in cardiac diseases

C01DX - Other vasodilators used in cardiac diseases

C01DX22 - Vericiguat


5.4 Absorption, Distribution and Excretion

Absorption

Following the administration of 10mg of vericiguat by mouth once daily, the average steady-state Cmax and AUC in patients with heart failure is 350 mcg/L and 6,680 mcgh/L, respectively, with a Tmax of 1 hour. The absolute bioavailability of orally-administered vericiguat is approximately 93% when taken with food - co-administration with meals has been shown to reduce pharmacokinetic variability, increase Tmax to roughly 4 hours, and increase Cmax and AUC by 41% and 44%, respectively.


Route of Elimination

Following the oral administration of radiolabeled vericiguat, approximately 53% of the administered radioactivity was recovered in the urine and 45% in the feces. A human mass balance study found that the portion recovered in the urine comprised approximately 40.8% N-glucuronide metabolite, 7.7% other metabolites, and 9% unchanged parent drug, while virtually the entire portion recovered in the feces comprised unchanged vericiguat.


Volume of Distribution

In healthy subjects the steady-state volume of distribution of vericiguat is approximately 44 liters.


Clearance

Vericiguat is a low-clearance drug, with an observed plasma clearance of 1.6 L/h in healthy volunteers and 1.3 L/h in patients with systolic heart failure.


5.5 Metabolism/Metabolites

Vericiguat is primarily metabolized via phase II conjugation reactions, with CYP-mediated oxidative metabolism comprising a small (<5%) portion of its overall biotransformation. The major inactive metabolite, vericiguat N-glucuronide (M1), is formed by UGT1A9 and, to a lesser extent, UGT1A1. Other identified metabolites include a denbenzylated compound and an M15 metabolite thought to be the result of oxidative metabolism, although these metabolites are poorly characterized.


5.6 Biological Half-Life

In patients with heart failure, the half-life of vericiguat is 30 hours.


5.7 Mechanism of Action

Heart failure (HF) involves, amongst other morphologic and physiologic changes, the impaired synthesis of nitric oxide (NO) and decreased activity of soluble guanylate cyclase (sGC). Functioning normally, NO binds to sGC and stimulates the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger involved in the maintenance of vascular tone, as well as cardiac contractility and remodeling. Defects in this pathway are thought to contribute to the myocardial and vascular dysfunction associated with heart failure and are therefore a desirable target in its treatment. Vericiguat directly stimulates sGC by binding to a target site on its beta-subunit, bypassing the need for NO-mediated activation, and in doing so causes an increase in the production of intracellular cGMP that results in vascular smooth muscle relaxation and vasodilation.


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Moehs Iberica

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Metrochem API Private Limited

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Shandong Loncom Pharmaceutical

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Sichuan Elixir Pharmaceuticals

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TAPI Technology & API Services

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MSN Laboratories

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Morepen Laboratories

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Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

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Vericiguat

About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...

Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 years, MOEHS has considerable technical experience in the production of these substances. At Moehs Group we have a large tradition and experience in the area of manufacturing of active pharmaceutical and veterinary ingredients, agrochemicals, nutraceutical, cosmetic, as well as fine chemistry in general, with high levels of quality and safety standards-GMP´s, ICH, approved by the FDA and TGA.
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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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Vericiguat

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 Economic Development...

Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.
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Virtual BoothSichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..

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Vericiguat

About the Company : Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ...

Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ANDA, 505b(2) and P-IV challenges. Exploring macromolecular APIs, we focus on Glycans & polypeptides. Expertise in XDC drugs drives innovative research & payload production. With a global registration platform & international cGMP system, we offer API CMO/CDMO services worldwide. Our strategy combines FDF and APIs. Our labs meet GMP standards with a stable R&D team, over 10 years of experience, we've delivered 20+ successful projects.
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About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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Vericiguat

About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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Vericiguat

About the Company : Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was fou...

Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was founded in 1949 by (Tan Ruiting) with a registered capital of 108 million yuan and the company was restructured as a Changzhou pharmaceutical Factory under the aegis of the Shanghai Pharma Group. The company mainly involves leading pharmaceutical manufacturers a wide range of key Intermediates, Active pharmaceutical ingredients, and Finished Formulations that meet with global standards.
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Vericiguat

About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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Vericiguat

About the Company : Morepen Laboratories Ltd.’ is 31 years old company. Went to public in 1993. Manufacturer and Exporter of complex and high margins molecules (APIs/Intermediates) for regulated mar...

Morepen Laboratories Ltd.’ is 31 years old company. Went to public in 1993. Manufacturer and Exporter of complex and high margins molecules (APIs/Intermediates) for regulated markets of USA, Europe, Russia, Canada and also for non-regulated markets. The first Morepen manufacturing plant was set up on the foothills of the Himalayas in the idyllic surroundings of Parwanoo. The large and spread-out facility is USDFA approved for manufacture of Loratadine, an anti-allergy drug- internationally known as Claritin.
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Vericiguat

About the Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide range of therapeutic cat...

Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide range of therapeutic categories specifically focusing on Anti-Fungal and Anti-Platelets. Our vision is to attain market leadership in development of innovator molecules for the domestic and export market.
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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"15000","totalValueFC":"3790.1","currency":"USD","unitRateINR":"1266000","date":"30-Apr-2024","totalValueINR":"316500","totalValueInUsd":"3790.1","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"3269619","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.518, LAO DONG EAST ROAD, CHANGZHOU JIANGSU 213018, CHINA. Changzhou, , China China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720636200,"product":"(FOC) 60013440 VERICIGUAT API 64574044","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"PLIVA HRVATSKA","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"0.08","actualQuantity":"80","unit":"GMS","unitRateFc":"34.4","totalValueFC":"3337.3","currency":"USD","unitRateINR":"3487.1","date":"11-Jul-2024","totalValueINR":"278968.75","totalValueInUsd":"3337.3","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4455377","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"PRILAZ BARUNA FILIPOVICA 25, 10000ZAGREBSDNF Croatia","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720636200,"product":"(FOC) 60013440 VERICIGUAT API 64575044","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"PLIVA HRVATSKA","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"0.08","actualQuantity":"80","unit":"GMS","unitRateFc":"34.4","totalValueFC":"3337.3","currency":"USD","unitRateINR":"3487.1","date":"11-Jul-2024","totalValueINR":"278968.75","totalValueInUsd":"3337.3","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4455377","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"PRILAZ BARUNA FILIPOVICA 25, 10000ZAGREBSDNF Croatia","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720636200,"product":"(FOC) 60013440 VERICIGUAT API 64576044","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"PLIVA HRVATSKA","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"0.08","actualQuantity":"80","unit":"GMS","unitRateFc":"34.4","totalValueFC":"3337.3","currency":"USD","unitRateINR":"3487.1","date":"11-Jul-2024","totalValueINR":"278968.75","totalValueInUsd":"3337.3","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4455377","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"PRILAZ BARUNA FILIPOVICA 25, 10000ZAGREBSDNF Croatia","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"}]
02-Jun-2023
11-Jul-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
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Average Price
(USD/KGS)
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Drugs in Development

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Details:

Bayer granted Dr. Reddy’s non-exclusive rights for Vericiguat under the brand name Gantra in India, indicated for adults with symptomatic chronic heart failure with reduced ejection fraction.


Lead Product(s): Vericiguat

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Gantra

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Dr. Reddy\'s Laboratories

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership April 05, 2024

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01

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Details : Bayer granted Dr. Reddy’s non-exclusive rights for Vericiguat under the brand name Gantra in India, indicated for adults with symptomatic chronic heart failure with reduced ejection fraction.

Brand Name : Gantra

Molecule Type : Small molecule

Upfront Cash : Undisclosed

April 05, 2024

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Details:

Verquvo (vericiguat) is an oral once daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the NO-sGC-cGMP signaling pathway and currently in pediatric patients aged > 28 days to 18 years with heart failure.


Lead Product(s): Vericiguat

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Verquvo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Merck & Co

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2023

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02

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Details : Verquvo (vericiguat) is an oral once daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the NO-sGC-cGMP signaling pathway and currently in pediatric patients aged > 28 days to 18 years with heart failure.

Brand Name : Verquvo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 01, 2023

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Details:

Verquvo (Vericiguat) 2.5 mg, 5 mg, and 10 mg is an oral once daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway.


Lead Product(s): Vericiguat

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Verquvo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 19, 2022

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03

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Details : Verquvo (Vericiguat) 2.5 mg, 5 mg, and 10 mg is an oral once daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway.

Brand Name : Verquvo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 19, 2022

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Details:

A pivotal Phase 3 (VICTOR) study has been initiated for VERQUVO® (vericiguat) in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event.


Lead Product(s): Vericiguat

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Verquvo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 11, 2021

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04

Merck & Co

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Merck & Co

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : A pivotal Phase 3 (VICTOR) study has been initiated for VERQUVO® (vericiguat) in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event.

Brand Name : Verquvo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 11, 2021

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Details:

VERQUVO is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway.


Lead Product(s): Vericiguat

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Verquvo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2021

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05

Merck & Co

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Merck & Co

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : VERQUVO is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway.

Brand Name : Verquvo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 21, 2021

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Details:

Vericiguat will be the first treatment option to have been studied specifically in patients after a recent decompensation in order to help break the cycle of worsening events, reduce the risk of re-hospitalization.


Lead Product(s): Vericiguat

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Verquvo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 21, 2021

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06

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Details : Vericiguat will be the first treatment option to have been studied specifically in patients after a recent decompensation in order to help break the cycle of worsening events, reduce the risk of re-hospitalization.

Brand Name : Verquvo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 21, 2021

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Details:

VERQUVO is approved for reduction of risk of cardiovascular death and heart failure (hf) hospitalization following a hospitalization for HF or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.


Lead Product(s): Vericiguat

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Verquvo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Bayer AG

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 20, 2021

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07

Merck & Co

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Merck & Co

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : VERQUVO is approved for reduction of risk of cardiovascular death and heart failure (hf) hospitalization following a hospitalization for HF or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fr...

Brand Name : Verquvo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 20, 2021

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Details:

Vericiguat is an investigational oral, once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator being developed to treat patients with symptomatic chronic heart failure with an ejection fraction less than 45%.


Lead Product(s): Vericiguat

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: BAY 1021189

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 28, 2020

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08

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Details : Vericiguat is an investigational oral, once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator being developed to treat patients with symptomatic chronic heart failure with an ejection fraction less than 45%.

Brand Name : BAY 1021189

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 28, 2020

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Details:

The application is based on results from the Phase 3 VICTORIA trial, which is the first contemporary outcomes study focused solely on a population with worsening chronic heart failure at high risk for cardiovascular mortality and repeated heart failure hospitalizations.


Lead Product(s): Vericiguat

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: MK-1242

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Bayer AG

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 16, 2020

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09

Merck & Co

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Merck & Co

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : The application is based on results from the Phase 3 VICTORIA trial, which is the first contemporary outcomes study focused solely on a population with worsening chronic heart failure at high risk for cardiovascular mortality and repeated heart failure h...

Brand Name : MK-1242

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 16, 2020

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Details:

Regulatory submissions based on positive data from Phase III VICTORIA study recently published in the New England Journal of Medicine.


Lead Product(s): Vericiguat

Therapeutic Area: Cardiology/Vascular Diseases 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 June 05, 2020

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10

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Bayer AG

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Details : Regulatory submissions based on positive data from Phase III VICTORIA study recently published in the New England Journal of Medicine.

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 05, 2020

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ABOUT THIS PAGE

Vericiguat Manufacturers

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

Vericiguat Suppliers

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

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

Vericiguat USDMF

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

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

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

Vericiguat 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 Vericiguat as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Vericiguat 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 Vericiguat 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 Vericiguat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vericiguat NDC to their finished compounded human drug products, they may choose to do so.

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

Vericiguat GMP

Vericiguat 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 Vericiguat 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 Vericiguat GMP manufacturer or Vericiguat GMP API supplier for your needs.

Vericiguat CoA

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

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

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