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panobinostat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| histone deacetylase inhibitors | 4682 | 404950-80-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An indole and hydroxamic acid derivative that acts as a HISTONE DEACETYLASE inhibitor. It is used as an antineoplastic agent in combination with BORTEZOMIB and DEXAMETHASONE for the treatment of MULTIPLE MYELOMA.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| CL (Clearance) | 10.20 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.10 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 13.10 hours | Lombardo F, Berellini G, Obach RS |
| BA (Bioavailability) | 30 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.193 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 3.864 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 3.622 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 8.730 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 24.960 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 36.050 | % | High | 1 |
| herg | hERG pIC50 | 4.901 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 6.745 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 11.588 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 21.750 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK2,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IGF1R,INSR,ITK,JAK1,JAK2,JAK3,KDR,KIT,MAP2K6,MAP3K21,MAP3K7,MAP4K1,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SIK2,SIK3,SRC,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70 | 65 | |||
| kinase-selectivity-class | AAK1,AKT2,AKT3,ALK,AURKC,AXL,BRAF,CAMK2D,CDK4,CDK6,CDK7,CDK9,DDR1,EPHB4,ERBB2,FLT3,GRK2,INSR,JAK2,MAP2K6,MAP3K7,MAPK12,MAPK7,MARK4,NTRK3,NUAK1,PAK4,PDK1,PDPK1,PRKCD,PRKG1,SIK2,SIK3,STK16,STK33,TEK,TNK1,ULK1,ULK2 | 39 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 6.138 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 111.944 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 17.650 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 7.129 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 38.140 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 51.050 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 76.020 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 20.040 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 568.853 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 28, 2015 | EMA | ||
| Feb. 23, 2015 | FDA | NOVARTIS PHARMS CORP |
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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 106.76 | 40.54 | 46 | 1439 | 106824 | 90520138 |
| Diarrhoea | 93.64 | 40.54 | 94 | 1391 | 939096 | 89687866 |
| Platelet count decreased | 83.81 | 40.54 | 42 | 1443 | 136927 | 90490035 |
| Thrombocytopenia | 72.38 | 40.54 | 44 | 1441 | 208681 | 90418281 |
| Death | 69.14 | 40.54 | 58 | 1427 | 456493 | 90170469 |
| Plasma cell myeloma | 62.77 | 40.54 | 24 | 1461 | 40804 | 90586158 |
| Plasmacytoma | 49.39 | 40.54 | 11 | 1474 | 2782 | 90624180 |
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 |
|---|---|---|---|---|---|---|
| Diarrhoea | 105.44 | 34.74 | 118 | 1898 | 460731 | 42158588 |
| Platelet count decreased | 98.58 | 34.74 | 68 | 1948 | 138513 | 42480806 |
| Malignant neoplasm progression | 78.86 | 34.74 | 54 | 1962 | 108346 | 42510973 |
| Morganella infection | 48.39 | 34.74 | 10 | 2006 | 609 | 42618710 |
| Bronchial haemorrhage | 47.11 | 34.74 | 10 | 2006 | 694 | 42618625 |
| Thrombocytopenia | 38.39 | 34.74 | 46 | 1970 | 190233 | 42429086 |
| Death | 36.55 | 34.74 | 73 | 1943 | 471112 | 42148207 |
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 |
|---|---|---|---|---|---|---|
| Platelet count decreased | 174.31 | 36.19 | 98 | 3070 | 230345 | 110355786 |
| Malignant neoplasm progression | 153.31 | 36.19 | 82 | 3086 | 174485 | 110411646 |
| Diarrhoea | 129.59 | 36.19 | 160 | 3008 | 1139345 | 109446786 |
| Thrombocytopenia | 82.78 | 36.19 | 73 | 3095 | 348812 | 110237319 |
| Plasma cell myeloma | 76.80 | 36.19 | 37 | 3131 | 62899 | 110523232 |
| Death | 67.61 | 36.19 | 91 | 3077 | 698778 | 109887353 |
| Plasmacytoma | 49.62 | 36.19 | 14 | 3154 | 5248 | 110580883 |
| White blood cell count decreased | 46.46 | 36.19 | 44 | 3124 | 229346 | 110356785 |
| Morganella infection | 45.40 | 36.19 | 10 | 3158 | 1369 | 110584762 |
| Bronchial haemorrhage | 45.34 | 36.19 | 10 | 3158 | 1377 | 110584754 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XH03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Histone deacetylase (HDAC) inhibitors |
| FDA MoA | N0000175071 | Histone Deacetylase Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D056572 | Histone Deacetylase Inhibitors |
| FDA EPC | N0000175588 | Histone Deacetylase Inhibitor |
| FDA MoA | N0000182137 | Cytochrome P450 2D6 Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50926 | angiogenesis modulating agent |
| CHEBI has role | CHEBI:61115 | EC 3.5.1.98 (histone deacetylase) inhibitor |
| CHEBI has role | CHEBI:64946 | anti-HIV agent |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| CHEBI has role | CHEBI:233423 | antifibrotic agent |
Related Drugs by ATC class:
L01XH Histone deacetylase (HDAC) inhibitors 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Multiple myeloma | indication | 109989006 | DOID:9538 |
| Primary cutaneous T-cell lymphoma | indication | 400122007 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.83 | acidic |
| pKa2 | 13.3 | acidic |
| pKa3 | 9.33 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 10MG BASE | FARYDAK | SECURA | N205353 | Feb. 23, 2015 | DISCN | CAPSULE | ORAL | 8883842 | June 13, 2028 | TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE |
| EQ 15MG BASE | FARYDAK | SECURA | N205353 | Feb. 23, 2015 | DISCN | CAPSULE | ORAL | 8883842 | June 13, 2028 | TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE |
| EQ 20MG BASE | FARYDAK | SECURA | N205353 | Feb. 23, 2015 | DISCN | CAPSULE | ORAL | 8883842 | June 13, 2028 | TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Histone deacetylase 11 | Enzyme | INHIBITOR | Ki | 8.46 | CHEMBL | DRUG LABEL | |||
| Histone deacetylase 3 | Enzyme | INHIBITOR | Ki | 8.96 | CHEMBL | DRUG LABEL | |||
| Histone deacetylase 6 | Enzyme | INHIBITOR | Ki | 9.15 | CHEMBL | DRUG LABEL | |||
| Histone deacetylase 7 | Enzyme | INHIBITOR | Ki | 8.64 | CHEMBL | DRUG LABEL | |||
| Histone deacetylase 8 | Enzyme | INHIBITOR | Ki | 7.66 | CHEMBL | DRUG LABEL | |||
| Histone deacetylase 4 | Enzyme | INHIBITOR | Ki | 9.22 | CHEMBL | DRUG LABEL | |||
| Histone deacetylase 9 | Enzyme | INHIBITOR | Ki | 8.92 | CHEMBL | DRUG LABEL | |||
| Histone deacetylase 10 | Enzyme | INHIBITOR | Ki | 7.51 | CHEMBL | DRUG LABEL | |||
| Histone deacetylase 5 | Enzyme | INHIBITOR | Ki | 9.15 | CHEMBL | DRUG LABEL | |||
| Histone deacetylase 2 | Enzyme | INHIBITOR | Ki | 9.19 | CHEMBL | DRUG LABEL | |||
| Histone deacetylase 1 | Enzyme | INHIBITOR | Ki | 9 | CHEMBL | DRUG LABEL | |||
| Bromodomain-containing protein 4 | Nuclear other | IC50 | 8.30 | CHEMBL | |||||
| Phosphatidylinositol 3-kinase catalytic subunit type 3 | Kinase | IC50 | 8.30 | CHEMBL | |||||
| Methylcytosine dioxygenase TET2 | Enzyme | IC50 | 5.42 | CHEMBL | |||||
| Histone deacetylase | Enzyme | IC50 | 8.74 | CHEMBL | |||||
| Histone deacetylase 8 | Enzyme | IC50 | 6.35 | CHEMBL | |||||
| Protein Tat | Transcription factor | EC50 | 6.89 | CHEMBL | |||||
| Histone deacetylase | Enzyme | IC50 | 8 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| D10019 | KEGG_DRUG |
| 960055-56-5 | SECONDARY_CAS_RN |
| 4034263 | VANDF |
| CHEBI:85990 | CHEBI |
| LBH | PDB_CHEM_ID |
| CHEMBL483254 | ChEMBL_ID |
| CHEMBL3545368 | ChEMBL_ID |
| 7489 | IUPHAR_LIGAND_ID |
| 8805 | INN_ID |
| DB06603 | DRUGBANK_ID |
| 9647FM7Y3Z | UNII |
| 1603349 | RXNORM |
| 232927 | MMSL |
| 30903 | MMSL |
| d08348 | MMSL |
| 015928 | NDDF |
| 015929 | NDDF |
| 32393311000001105 | SNOMEDCT_US |
| 429068009 | SNOMEDCT_US |
| 429398005 | SNOMEDCT_US |
| 734519004 | SNOMEDCT_US |
| C1998098 | UMLSCUI |
| D000077767 | MESH_DESCRIPTOR_UI |
| 6918837 | PUBCHEM_CID |
| 9647FM7Y3Z | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| FARYDAK | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73116-100 | CAPSULE | 10 mg | ORAL | NDA | 34 sections |
| FARYDAK | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73116-101 | CAPSULE | 15 mg | ORAL | NDA | 34 sections |
| FARYDAK | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73116-102 | CAPSULE | 20 mg | ORAL | NDA | 34 sections |