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nerandomilast 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| phosphodiesterase IV (PDE IV) inhibitors | 5785 | 1423719-30-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Nerandomilast is a selective inhibitor of phosphodiesterase 4 (PDE4) with preferential inhibition of the PDE4B isoenzyme over PDE4A, C and D. There is a 9-fold selectivity over PDE4D, 24-fold selectivity over PDE4A and 870-fold selectivity over PDE4C based on in vitro data. At the recommended doses, inhibition of PDE4B and weaker inhibition of PDE4D can be expected. PDE4 hydrolyses and inactivates cyclic adenosine monophosphate (cAMP). Nerandomilast exerts both anti-fibrotic and immunomodulatory effects as preferential PDE4B inhibition elevates intracellular cAMP levels and reduces the expression of pro-fibrotic growth factors and inflammatory cytokines, which are overexpressed in fibrotic lung disease.
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 |
|---|---|---|---|
| Oct. 7, 2025 | FDA | Boehringer Ingelheim |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L04AA61 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants |
| CHEBI has role | CHEBI:233423 | antifibrotic agent |
Related Drugs by ATC class:
L04AA Selective immunosuppressants 10 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Idiopathic pulmonary fibrosis | indication | 700250006 | DOID:0050156 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 18MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 8754073 | Nov. 26, 2029 | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS |
| 9MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 8754073 | Nov. 26, 2029 | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS |
| 18MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 9802954 | Feb. 19, 2034 | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS |
| 9MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 9802954 | Feb. 19, 2034 | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS |
| 18MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 11406638 | Oct. 22, 2038 | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF |
| 18MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 11406638 | Oct. 22, 2038 | TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF |
| 18MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 11813266 | Oct. 22, 2038 | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB MONOETHANESULFONATE |
| 18MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 11813266 | Oct. 22, 2038 | TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB MONOETHANESULFONATE |
| 9MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 11406638 | Oct. 22, 2038 | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF |
| 9MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 11406638 | Oct. 22, 2038 | TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF |
| 9MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 11813266 | Oct. 22, 2038 | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB MONOETHANESULFONATE |
| 9MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | 11813266 | Oct. 22, 2038 | TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB MONOETHANESULFONATE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 18MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | Dec. 19, 2028 | TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS (PPF) IN ADULT PATIENTS |
| 9MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | Dec. 19, 2028 | TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS (PPF) IN ADULT PATIENTS |
| 18MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | Oct. 7, 2030 | NEW CHEMICAL ENTITY |
| 9MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | Oct. 7, 2030 | NEW CHEMICAL ENTITY |
| 18MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | Oct. 7, 2032 | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (IPF) IN ADULT PATIENTS |
| 9MG | JASCAYD | BOEHRINGER INGELHEIM | N218764 | Oct. 7, 2025 | RX | TABLET | ORAL | Oct. 7, 2032 | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (IPF) IN ADULT PATIENTS |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| cAMP-specific 3',5'-cyclic phosphodiesterase 4B | Enzyme | INHIBITOR | IC50 | 7.99 | DRUG LABEL | DRUG LABEL | |||
| cAMP-specific 3',5'-cyclic phosphodiesterase 4A | Enzyme | INHIBITOR | IC50 | 6.61 | IUPHAR | ||||
| cGMP-inhibited 3',5'-cyclic phosphodiesterase A | Enzyme | INHIBITOR | IC50 | 6.92 | DRUG LABEL | ||||
| cAMP-specific 3',5'-cyclic phosphodiesterase 4D | Enzyme | INHIBITOR | IC50 | 7.04 | DRUG LABEL | ||||
| High affinity cAMP-specific 3',5'-cyclic phosphodiesterase 7A | Enzyme | INHIBITOR | IC50 | 7.86 | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL5314532 | ChEMBL_ID |
| C000727475 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4044317 | VANDF |
| C5853434 | UMLSCUI |
| CHEBI:759233 | CHEBI |
| 12674 | INN_ID |
| D12975 | KEGG_DRUG |
| 166177189 | PUBCHEM_CID |
| 398396 | MMSL |
| 44459 | MMSL |
| d10330 | MMSL |
| 020269 | NDDF |
| 12518 | IUPHAR_LIGAND_ID |
| I5DGT51IB8 | UNII |
| 2725523 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| JASCAYD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0597-2465 | TABLET, FILM COATED | 9 mg | ORAL | NDA | 30 sections |
| JASCAYD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0597-7313 | TABLET, FILM COATED | 18 mg | ORAL | NDA | 30 sections |