tecovirimat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals | 5291 | 869572-92-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Tecovirimat targets and inhibits the activity of the orthopoxvirus VP37 protein (encoded by and highly conserved in all members of the orthopoxvirus genus) and blocks its interaction with cellular Rab9 GTPase and TIP47, which prevents the formation of egress-competent enveloped virions necessary for cell-to-cell and long-range dissemination of virus.
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 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 6, 2022 | EMA | SIGA TECHNOLOGIES NETHERLANDS B.V. | |
| July 13, 2018 | FDA | SIGA TECHNOLOGIES |
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 | J05AX24 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Other antivirals |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000998 | Antiviral Agents |
| FDA MoA | N0000182140 | Cytochrome P450 2C19 Inhibitors |
| FDA MoA | N0000187062 | Cytochrome P450 2C8 Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| FDA MoA | N0000190118 | Cytochrome P450 3A Inducers |
| FDA EPC | N0000193857 | Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Smallpox | indication | 67924001 | DOID:8736 |
| Cowpox | indication | 70090004 | DOID:8956 |
| Monkeypox | indication | 359814004 | DOID:3292 |
| Complications due to replication of vaccinia virus following vaccination against smallpox | indication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.13 | acidic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 200MG | TPOXX | SIGA TECHNOLOGIES | N208627 | July 13, 2018 | RX | CAPSULE | ORAL | 8802714 | June 18, 2024 | TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG |
| 200MG/20ML (10MG/ML) | TPOXX | SIGA TECHNOLOGIES | N214518 | May 18, 2022 | RX | SOLUTION | INTRAVENOUS | 8802714 | June 18, 2024 | TPOXX IS INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 3 KG |
| 200MG/20ML (10MG/ML) | TPOXX | SIGA TECHNOLOGIES | N214518 | May 18, 2022 | RX | SOLUTION | INTRAVENOUS | 9907859 | Aug. 2, 2031 | TPOXX IS INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 3 KG |
| 200MG | TPOXX | SIGA TECHNOLOGIES | N208627 | July 13, 2018 | RX | CAPSULE | ORAL | 7737168 | Sept. 4, 2031 | TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG |
| 200MG/20ML (10MG/ML) | TPOXX | SIGA TECHNOLOGIES | N214518 | May 18, 2022 | RX | SOLUTION | INTRAVENOUS | 7737168 | Sept. 4, 2031 | TPOXX IS INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 3 KG |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 200MG | TPOXX | SIGA TECHNOLOGIES | N208627 | July 13, 2018 | RX | CAPSULE | ORAL | July 13, 2023 | NEW CHEMICAL ENTITY |
| 200MG/20ML (10MG/ML) | TPOXX | SIGA TECHNOLOGIES | N214518 | May 18, 2022 | RX | SOLUTION | INTRAVENOUS | July 13, 2023 | NEW CHEMICAL ENTITY |
| 200MG | TPOXX | SIGA TECHNOLOGIES | N208627 | July 13, 2018 | RX | CAPSULE | ORAL | July 13, 2025 | INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Envelope protein F13 | Viral envelope protein | INHIBITOR | EC50 | 7.38 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| F925RR824R | UNII |
| 1162664-19-8 | SECONDARY_CAS_RN |
| C2713595 | UMLSCUI |
| CHEMBL1257073 | ChEMBL_ID |
| CHEMBL1242629 | ChEMBL_ID |
| 16124688 | PUBCHEM_CID |
| DB12020 | DRUGBANK_ID |
| D09390 | KEGG_DRUG |
| 9011 | INN_ID |
| 40695 | MMSL |
| d09893 | MMSL |
| 017694 | NDDF |
| 772991002 | SNOMEDCT_US |
| 773289005 | SNOMEDCT_US |
| 4039493 | VANDF |
| 2055104 | RXNORM |
| C505045 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TPOXX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50072-010 | INJECTION, SOLUTION, CONCENTRATE | 10 mg | INTRAVENOUS | NDA | 30 sections |
| TPOXX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50072-010 | INJECTION, SOLUTION, CONCENTRATE | 10 mg | INTRAVENOUS | NDA | 30 sections |
| TPOXX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50072-010 | INJECTION, SOLUTION, CONCENTRATE | 10 mg | INTRAVENOUS | NDA | 30 sections |
| TPOXX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50072-200 | CAPSULE | 200 mg | ORAL | NDA | 30 sections |
| TPOXX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50072-200 | CAPSULE | 200 mg | ORAL | NDA | 30 sections |
| TPOXX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50072-200 | CAPSULE | 200 mg | ORAL | NDA | 30 sections |
| TPOXX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50072-200 | CAPSULE | 200 mg | ORAL | NDA | 30 sections |