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| Stem definition | Drug id | CAS RN |
|---|---|---|
| phosphatidylinositol 3-kinase inhibitors, antineoplastics | 5836 | 2060571-02-8 |
| Dose | Unit | Route |
|---|---|---|
| 9 | mg | O |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 10, 2024 | FDA | Genentech (Roche) | |
| July 18, 2025 | EMA | Roche Registration GmbH |
| 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 |
|---|---|---|---|---|---|---|
| Hyperglycaemia | 291.45 | 57.18 | 67 | 535 | 50903 | 90576942 |
| Blood glucose increased | 115.30 | 57.18 | 37 | 565 | 95209 | 90532636 |
None
| 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 |
|---|---|---|---|---|---|---|
| Hyperglycaemia | 107.62 | 55.27 | 30 | 386 | 85060 | 110503823 |
| Blood glucose increased | 74.12 | 55.27 | 25 | 391 | 132471 | 110456412 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L01EM06 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Phosphatidylinositol-3-kinase (Pi3K) inhibitors |
| MeSH PA | D000081082 | Phosphoinositide-3 Kinase Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000194130 | Phosphoinositide 3-Kinase alpha Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Locally advanced or metastatic breast cancer | indication | 254837009 | DOID:1612 |
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 3MG | ITOVEBI | GENENTECH INC | N219249 | Oct. 10, 2024 | RX | TABLET | ORAL | 8343955 | Sept. 27, 2030 | COMBINATION WITH PALBOCICLIB AND FULVESTRANT FOR TREATMENT OF ADULTS WITH ENDOCRINE-RESISTANT PIK3CA-MUTATED HR-POSITIVE HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING RECURRENCE ON OR AFTER COMPLETING ADJUVANT ENDOCRINE THERAPY |
| 9MG | ITOVEBI | GENENTECH INC | N219249 | Oct. 10, 2024 | RX | TABLET | ORAL | 8343955 | Sept. 27, 2030 | COMBINATION WITH PALBOCICLIB AND FULVESTRANT FOR TREATMENT OF ADULTS WITH ENDOCRINE-RESISTANT PIK3CA-MUTATED HR-POSITIVE HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING RECURRENCE ON OR AFTER COMPLETING ADJUVANT ENDOCRINE THERAPY |
| 3MG | ITOVEBI | GENENTECH INC | N219249 | Oct. 10, 2024 | RX | TABLET | ORAL | 11760753 | July 1, 2036 | COMBINATION WITH PALBOCICLIB AND FULVESTRANT FOR TREATMENT OF ADULTS WITH ENDOCRINE-RESISTANT PIK3CA-MUTATED HR-POSITIVE HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING RECURRENCE ON OR AFTER COMPLETING ADJUVANT ENDOCRINE THERAPY |
| 3MG | ITOVEBI | GENENTECH INC | N219249 | Oct. 10, 2024 | RX | TABLET | ORAL | 9650393 | July 1, 2036 | COMBINATION WITH PALBOCICLIB AND FULVESTRANT FOR TREATMENT OF ADULTS WITH ENDOCRINE-RESISTANT PIK3CA-MUTATED HR-POSITIVE HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING RECURRENCE ON OR AFTER COMPLETING ADJUVANT ENDOCRINE THERAPY |
| 9MG | ITOVEBI | GENENTECH INC | N219249 | Oct. 10, 2024 | RX | TABLET | ORAL | 11760753 | July 1, 2036 | COMBINATION WITH PALBOCICLIB AND FULVESTRANT FOR TREATMENT OF ADULTS WITH ENDOCRINE-RESISTANT PIK3CA-MUTATED HR-POSITIVE HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING RECURRENCE ON OR AFTER COMPLETING ADJUVANT ENDOCRINE THERAPY |
| 9MG | ITOVEBI | GENENTECH INC | N219249 | Oct. 10, 2024 | RX | TABLET | ORAL | 9650393 | July 1, 2036 | COMBINATION WITH PALBOCICLIB AND FULVESTRANT FOR TREATMENT OF ADULTS WITH ENDOCRINE-RESISTANT PIK3CA-MUTATED HR-POSITIVE HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING RECURRENCE ON OR AFTER COMPLETING ADJUVANT ENDOCRINE THERAPY |
| 3MG | ITOVEBI | GENENTECH INC | N219249 | Oct. 10, 2024 | RX | TABLET | ORAL | 12410189 | June 14, 2038 | COMBINATION WITH PALBOCICLIB AND FULVESTRANT FOR TREATMENT OF ADULTS WITH ENDOCRINE-RESISTANT PIK3CA-MUTATED HR-POSITIVE HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING RECURRENCE ON OR AFTER COMPLETING ADJUVANT ENDOCRINE THERAPY |
| 9MG | ITOVEBI | GENENTECH INC | N219249 | Oct. 10, 2024 | RX | TABLET | ORAL | 12410189 | June 14, 2038 | COMBINATION WITH PALBOCICLIB AND FULVESTRANT FOR TREATMENT OF ADULTS WITH ENDOCRINE-RESISTANT PIK3CA-MUTATED HR-POSITIVE HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING RECURRENCE ON OR AFTER COMPLETING ADJUVANT ENDOCRINE THERAPY |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 3MG | ITOVEBI | GENENTECH INC | N219249 | Oct. 10, 2024 | RX | TABLET | ORAL | Oct. 10, 2029 | NEW CHEMICAL ENTITY |
| 9MG | ITOVEBI | GENENTECH INC | N219249 | Oct. 10, 2024 | RX | TABLET | ORAL | Oct. 10, 2029 | NEW CHEMICAL ENTITY |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform | Kinase | INHIBITOR | IC50 | 10.42 | DRUG LABEL | DRUG LABEL | |||
| Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform | Kinase | INHIBITOR | Ki | 7.74 | IUPHAR | ||||
| Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform | Kinase | INHIBITOR | Ki | 7.91 | IUPHAR | ||||
| Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform | Kinase | INHIBITOR | Ki | 7 | IUPHAR |
| ID | Source |
|---|---|
| MWF | PDB_CHEM_ID |
| CHEMBL4650215 | ChEMBL_ID |
| C000723546 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB15275 | DRUGBANK_ID |
| 4043515 | VANDF |
| C5446307 | UMLSCUI |
| CHEBI:758122 | CHEBI |
| 11204 | INN_ID |
| 124173720 | PUBCHEM_CID |
| 43338 | MMSL |
| d10228 | MMSL |
| 9636 | IUPHAR_LIGAND_ID |
| L4C1UY2NYH | UNII |
| 2695422 | RXNORM |
| 933451381000036107 | SNOMEDCT_US |
| D11942 | KEGG_DRUG |
| 019886 | NDDF |
| L4C1UY2NYH | INXIGHT DRUGS |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Itovebi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-079 | TABLET, FILM COATED | 9 mg | ORAL | NDA | 31 sections |
| Itovebi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-079 | TABLET, FILM COATED | 9 mg | ORAL | NDA | 31 sections |
| Itovebi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-084 | TABLET, FILM COATED | 3 mg | ORAL | NDA | 31 sections |
| Itovebi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-084 | TABLET, FILM COATED | 3 mg | ORAL | NDA | 31 sections |