| Stem definition | Drug id | CAS RN |
|---|---|---|
| guanylate cyclase activators and stimulators | 5439 | 1350653-20-1 |
| Dose | Unit | Route |
|---|---|---|
| 10 | mg | O |
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 16, 2021 | EMA | BAYER AG | |
| Jan. 19, 2021 | FDA | MERCK SHARP DOHME | |
| June 23, 2021 | PMDA | BAYER YAKUHIN, Ltd. |
None
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hypotension | 66.67 | 63.64 | 31 | 203 | 221618 | 34735079 |
None
None
| Source | Code | Description |
|---|---|---|
| ATC | C01DX22 | CARDIOVASCULAR SYSTEM CARDIAC THERAPY VASODILATORS USED IN CARDIAC DISEASES Other vasodilators used in cardiac diseases |
| FDA MoA | N0000190484 | Guanylate Cyclase Stimulators |
| FDA EPC | N0000190485 | Soluble Guanylate Cyclase Stimulator |
| CHEBI has role | CHEBI:35620 | vasodilator agents |
| CHEBI has role | CHEBI:35674 | antihypertensive drugs |
| CHEBI has role | CHEBI:76022 | soluble guanylyl cyclase activators |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic heart failure | indication | 48447003 | |
| Heart failure | indication | 84114007 | DOID:6000 |
| Pregnancy, function | contraindication | 289908002 |
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 11439642 | May 19, 2031 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 10MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 8921377 | May 19, 2031 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 10MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 9993476 | May 19, 2031 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 2.5MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 11439642 | May 19, 2031 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 2.5MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 8921377 | May 19, 2031 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 2.5MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 9993476 | May 19, 2031 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 5MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 11439642 | May 19, 2031 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 5MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 8921377 | May 19, 2031 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 5MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 9993476 | May 19, 2031 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 10MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 9604948 | Nov. 26, 2032 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 2.5MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 9604948 | Nov. 26, 2032 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| 5MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | 9604948 | Nov. 26, 2032 | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | Jan. 19, 2026 | NEW CHEMICAL ENTITY |
| 2.5MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | Jan. 19, 2026 | NEW CHEMICAL ENTITY |
| 5MG | VERQUVO | MERCK SHARP DOHME | N214377 | Jan. 19, 2021 | RX | TABLET | ORAL | Jan. 19, 2026 | NEW CHEMICAL ENTITY |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Guanylate cyclase soluble subunit beta-1 | Enzyme | ACTIVATOR | DRUG LABEL | DRUG LABEL | |||||
| Guanylate cyclase soluble subunit beta-1 | Enzyme | ACTIVATOR | EC50 | 6 | SCIENTIFIC LITERATURE |
| ID | Source |
|---|---|
| D11051 | KEGG_DRUG |
| LV66ADM269 | UNII |
| C4078709 | UMLSCUI |
| CHEBI:142432 | CHEBI |
| CHEMBL4066936 | ChEMBL_ID |
| 54674461 | PUBCHEM_CID |
| DB15456 | DRUGBANK_ID |
| 10010 | IUPHAR_LIGAND_ID |
| 018619 | NDDF |
| 1145150000 | SNOMEDCT_US |
| 1145164000 | SNOMEDCT_US |
| 4040006 | VANDF |
| 2475830 | RXNORM |
| 342963 | MMSL |
| 39282 | MMSL |
| d09705 | MMSL |
| C000603960 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9805 | INN_ID |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| VERQUVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5028 | TABLET, FILM COATED | 2.50 mg | ORAL | NDA | 33 sections |
| VERQUVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5028 | TABLET, FILM COATED | 2.50 mg | ORAL | NDA | 33 sections |
| VERQUVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5028 | TABLET, FILM COATED | 2.50 mg | ORAL | NDA | 33 sections |
| VERQUVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5029 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 33 sections |
| VERQUVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5029 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 33 sections |
| VERQUVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5029 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 33 sections |
| VERQUVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5030 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 33 sections |
| VERQUVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5030 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 33 sections |
| VERQUVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5030 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 33 sections |