trofinetide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| natriuretic peptides | 5714 | 853400-76-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Trofinetide is a chemically modified analog of GPE (glycine-proline-glutamate), an endogenous peptide produced by N-terminal cleavage of IGF-1. The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 10, 2023 | FDA | ACADIA PHARMS INC |
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 |
|---|---|---|
| FDA MoA | N0000182141 | Cytochrome P450 3A4 Inhibitors |
| FDA MoA | N0000190107 | Organic Anion Transporting Polypeptide 1B1 Inhibitors |
| FDA MoA | N0000190108 | Organic Anion Transporting Polypeptide 1B3 Inhibitors |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Rett syndrome | indication | 68618008 | DOID:1206 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 200MG/ML | DAYBUE | ACADIA PHARMS INC | N217026 | March 10, 2023 | RX | SOLUTION | ORAL | 9212204 | Jan. 27, 2032 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 200MG/ML | DAYBUE | ACADIA PHARMS INC | N217026 | March 10, 2023 | RX | SOLUTION | ORAL | March 10, 2028 | NEW CHEMICAL ENTITY |
| 200MG/ML | DAYBUE | ACADIA PHARMS INC | N217026 | March 10, 2023 | RX | SOLUTION | ORAL | March 10, 2030 | TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| CHEMBL197084 | ChEMBL_ID |
| C000656362 | MESH_SUPPLEMENTAL_RECORD_UI |
| C540294 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12482 | IUPHAR_LIGAND_ID |
| DB06045 | DRUGBANK_ID |
| 019343 | NDDF |
| 4042121 | VANDF |
| C4726916 | UMLSCUI |
| 10076 | INN_ID |
| 11318905 | PUBCHEM_CID |
| 2632852 | RXNORM |
| D12400 | KEGG_DRUG |
| Z2ME8F52QL | UNII |
| 365641 | MMSL |
| 41304 | MMSL |
| d10021 | MMSL |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Daybue | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63090-660 | SOLUTION | 200 mg | ORAL | NDA | 28 sections |