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romidepsin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| depsipeptide derivatives | 4119 | 128517-07-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a bicyclic depsipeptide and a potent histone deacetylase inhibitor from Chromobacterium violaceum
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.64 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| Vd (Volume of distribution) | 1.20 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 7.40 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.07 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 11 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,PDK1,PDK2,PDK4,PRKDC,TEK | 16 | |||
| kinase-selectivity-class | BRAF,GRK2,PDK1 | 3 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 3, 2017 | PMDA | Celgene KK | |
| Nov. 5, 2009 | FDA | CELGENE |
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 |
|---|---|---|---|---|---|---|
| Electrocardiogram QT prolonged | 114.22 | 44.03 | 39 | 959 | 72417 | 90555032 |
| Platelet count decreased | 61.63 | 44.03 | 30 | 968 | 136939 | 90490510 |
| Thrombocytopenia | 60.41 | 44.03 | 34 | 964 | 208691 | 90418758 |
| Atrial fibrillation | 53.36 | 44.03 | 27 | 971 | 133584 | 90493865 |
| Tumour lysis syndrome | 47.81 | 44.03 | 13 | 985 | 11139 | 90616310 |
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 |
|---|---|---|---|---|---|---|
| Thrombocytopenia | 57.17 | 37.08 | 45 | 1144 | 190234 | 42429912 |
| Disease progression | 49.71 | 37.08 | 37 | 1152 | 143619 | 42476527 |
| Platelet count decreased | 46.39 | 37.08 | 35 | 1154 | 138546 | 42481600 |
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 | 104.08 | 38.40 | 60 | 1972 | 230383 | 110356884 |
| Thrombocytopenia | 99.94 | 38.40 | 68 | 1964 | 348817 | 110238450 |
| Atrial fibrillation | 85.93 | 38.40 | 53 | 1979 | 229589 | 110357678 |
| Malignant neoplasm progression | 59.45 | 38.40 | 38 | 1994 | 174529 | 110412738 |
| Therapy partial responder | 55.25 | 38.40 | 22 | 2010 | 37039 | 110550228 |
| Disease progression | 52.33 | 38.40 | 40 | 1992 | 243994 | 110343273 |
| Tumour lysis syndrome | 48.41 | 38.40 | 19 | 2013 | 30782 | 110556485 |
| Pyrexia | 46.90 | 38.40 | 69 | 1963 | 898196 | 109689071 |
| Death | 39.78 | 38.40 | 56 | 1976 | 698813 | 109888454 |
| Cytopenia | 38.44 | 38.40 | 16 | 2016 | 30100 | 110557167 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XH02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Histone deacetylase (HDAC) inhibitors |
| FDA MoA | N0000175071 | Histone Deacetylase Inhibitors |
| MeSH PA | D000903 | Antibiotics, Antineoplastic |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D056572 | Histone Deacetylase Inhibitors |
| FDA EPC | N0000175588 | Histone Deacetylase Inhibitor |
| FDA MoA | N0000187061 | Organic Cation Transporter 2 Inhibitors |
| FDA MoA | N0000190107 | Organic Anion Transporting Polypeptide 1B1 Inhibitors |
| FDA MoA | N0000190108 | Organic Anion Transporting Polypeptide 1B3 Inhibitors |
| FDA MoA | N0000190110 | Organic Anion Transporter 1 Inhibitors |
| FDA MoA | N0000193845 | Bile Salt Export Pump Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:61115 | EC 3.5.1.98 (histone deacetylase) inhibitor |
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 |
|---|---|---|---|
| Peripheral T-cell lymphoma | indication | 109977009 | |
| Primary cutaneous T-cell lymphoma | indication | 400122007 | |
| Hypokalemia | contraindication | 43339004 | |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Lymphocytopenia | contraindication | 48813009 | DOID:614 |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Chronic renal failure syndrome | contraindication | 90688005 | |
| Prolonged QT interval | contraindication | 111975006 | |
| Acute disease of cardiovascular system | contraindication | 128487001 | |
| Hypomagnesemia | contraindication | 190855004 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Pregnancy, function | contraindication | 289908002 | |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Congenital long QT syndrome | contraindication | 442917000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.47 | acidic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 27.5MG/5.5ML (5MG/ML) | ROMIDEPSIN | AMNEAL | A219099 | June 2, 2026 | RX | SOLUTION | INTRAVENOUS | Dec. 7, 2026 | COMPETITIVE GENERIC THERAPY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Histone deacetylase | Enzyme | INHIBITOR | Ki | 5.96 | IUPHAR | DRUG LABEL | |||
| Histone deacetylase 2 | Enzyme | IC50 | 7.33 | WOMBAT-PK | |||||
| Histone deacetylase 1 | Enzyme | IC50 | 7 | WOMBAT-PK | |||||
| Histone deacetylase 3 | Enzyme | Ki | 7.60 | WOMBAT-PK | |||||
| Histone deacetylase 6 | Enzyme | Ki | 6.52 | WOMBAT-PK | |||||
| Histone deacetylase 7 | Enzyme | INHIBITOR | Ki | 5.90 | IUPHAR | ||||
| Histone deacetylase 8 | Enzyme | INHIBITOR | Ki | 9.82 | IUPHAR | ||||
| Histone deacetylase 5 | Enzyme | INHIBITOR | Ki | 6.26 | IUPHAR | ||||
| Histone deacetylase 9 | Enzyme | INHIBITOR | Ki | 5.96 | IUPHAR | ||||
| Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform | Kinase | IC50 | 4.24 | CHEMBL | |||||
| Bromodomain-containing protein 4 | Nuclear other | IC50 | 7.44 | CHEMBL | |||||
| Histone deacetylase 3/Nuclear receptor corepressor 2 (HDAC3/NCoR2) | Transcription factor | IC50 | 7.74 | CHEMBL | |||||
| Histone deacetylase 3/NCoR1 | Transcription factor | Ki | 9.82 | CHEMBL | |||||
| Histone deacetylase 4 | Enzyme | IC50 | 6.29 | WOMBAT-PK | |||||
| Histone deacetylase 6 | Enzyme | IC50 | 6.41 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4029461 | VUID |
| N0000180306 | NUI |
| D06637 | KEGG_DRUG |
| 4029461 | VANDF |
| C1527027 | UMLSCUI |
| CHEBI:61080 | CHEBI |
| CHEMBL343448 | ChEMBL_ID |
| DB06176 | DRUGBANK_ID |
| C087123 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7006 | IUPHAR_LIGAND_ID |
| 8656 | INN_ID |
| CX3T89XQBK | UNII |
| 5352062 | PUBCHEM_CID |
| 877436 | RXNORM |
| 169125 | MMSL |
| 267261 | MMSL |
| 26838 | MMSL |
| d07512 | MMSL |
| 013396 | NDDF |
| 444608004 | SNOMEDCT_US |
| 444737005 | SNOMEDCT_US |
| CX3T89XQBK | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ROMIDEPSIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70121-2250 | INJECTION, SOLUTION, CONCENTRATE | 5 mg | INTRAVENOUS | ANDA | 28 sections |