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ensifentrine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| inhibitors of phosphodiesterases | 5826 | 497223-25-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ensifentrine is a first-in-class dual inhibitor of phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4). Inhibition of PDE3 and PDE4 increases intracellular cyclic adenosine monophosphate (cAMP) levels.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 26, 2024 | FDA | Verona Pharma, Inc. |
FDA Adverse Event Reporting System (Female)
| 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 |
|---|---|---|---|---|---|---|
| Dyspnoea | 70.05 | 42.56 | 44 | 344 | 880911 | 89747148 |
| Chronic obstructive pulmonary disease | 47.43 | 42.56 | 16 | 372 | 73813 | 90554246 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Dyspnoea | 81.34 | 52.49 | 44 | 238 | 442577 | 42178476 |
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Dyspnoea | 90.53 | 38.07 | 59 | 478 | 1106813 | 109481949 |
| Chronic obstructive pulmonary disease | 57.19 | 38.07 | 21 | 516 | 109137 | 110479625 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | R03BX02 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Other drugs for obstructive airway diseases, inhalants |
| FDA MoA | N0000175086 | Phosphodiesterase 3 Inhibitors |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D010726 | Phosphodiesterase Inhibitors |
| MeSH PA | D058987 | Phosphodiesterase 3 Inhibitors |
| MeSH PA | D058988 | Phosphodiesterase 4 Inhibitors |
| FDA EPC | N0000175598 | Phosphodiesterase 3 Inhibitor |
| FDA MoA | N0000182960 | Phosphodiesterase 4 Inhibitors |
| FDA EPC | N0000182961 | Phosphodiesterase 4 Inhibitor |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:65023 | anti-asthmatic agent |
Related Drugs by ATC class:
R03BX Other drugs for obstructive airway diseases, inhalants 1 drug
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic obstructive lung disease | indication | 13645005 | DOID:3083 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 3MG/2.5ML | OHTUVAYRE | MSD | N217389 | June 26, 2024 | RX | SUSPENSION | INHALATION | 9062047 | Aug. 21, 2031 | FOR THE MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) IN ADULT PATIENTS |
| 3MG/2.5ML | OHTUVAYRE | MSD | N217389 | June 26, 2024 | RX | SUSPENSION | INHALATION | 9956171 | Sept. 15, 2035 | FOR THE MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) IN ADULT PATIENTS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 3MG/2.5ML | OHTUVAYRE | MSD | N217389 | June 26, 2024 | RX | SUSPENSION | INHALATION | June 26, 2029 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| cGMP-inhibited 3',5'-cyclic phosphodiesterase A | Enzyme | INHIBITOR | IC50 | 9.60 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| cAMP-specific 3',5'-cyclic phosphodiesterase 4B | Enzyme | INHIBITOR | IC50 | 6.75 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| cAMP-specific 3',5'-cyclic phosphodiesterase 4D | Enzyme | INHIBITOR | IC50 | 7.33 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| cGMP-inhibited 3',5'-cyclic phosphodiesterase B | Enzyme | INHIBITOR | IC50 | 9.54 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| cAMP-specific 3',5'-cyclic phosphodiesterase 4A | Enzyme | INHIBITOR | IC50 | 5.83 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| 1884461-72-6 | SECONDARY_CAS_RN |
| CHEMBL4594287 | ChEMBL_ID |
| C512996 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB16157 | DRUGBANK_ID |
| 4043256 | VANDF |
| C1744503 | UMLSCUI |
| CHEBI:757790 | CHEBI |
| 10726 | INN_ID |
| 9934746 | PUBCHEM_CID |
| 386947 | MMSL |
| 42949 | MMSL |
| d10199 | MMSL |
| 019797 | NDDF |
| 11865 | IUPHAR_LIGAND_ID |
| 3E3D8T1GIX | UNII |
| 2687215 | RXNORM |
| D11743 | KEGG_DRUG |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Ohtuvayre | HUMAN PRESCRIPTION DRUG LABEL | 1 | 83034-003 | SUSPENSION | 3 mg | RESPIRATORY (INHALATION) | NDA | 30 sections |