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trofinetide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIM2,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 | 43 | |||
| kinase-selectivity-class | ACVR2B,AXL,BRAF,CDK9,EIF2AK3,EPHB4,GRK2,MAP2K6,MAP3K14,MAPK7,STK33,TEK,TGFBR1 | 13 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 10, 2023 | FDA | ACADIA PHARMS INC |
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 |
|---|---|---|---|---|---|---|
| Diarrhoea | 149.77 | 72.39 | 72 | 298 | 939118 | 89688959 |
| Underdose | 144.26 | 72.39 | 35 | 335 | 53982 | 90574095 |
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Diarrhoea | 88.24 | 73.95 | 39 | 131 | 1139466 | 109449663 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N07XX24 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
| 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 |
| CHEBI has role | CHEBI:63726 | neuroprotective agent |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| CHEBI has role | CHEBI:73336 | vulnerary |
Related Drugs by ATC class:
N07XX Other nervous system drugs 23 drugs
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 |
| 5000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | 9212204 | Jan. 27, 2032 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
| 6000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | 9212204 | Jan. 27, 2032 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
| 8000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | 9212204 | Jan. 27, 2032 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
| 200MG/ML | DAYBUE | ACADIA PHARMS INC | N217026 | March 10, 2023 | RX | SOLUTION | ORAL | 11827600 | July 12, 2042 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
| 200MG/ML | DAYBUE | ACADIA PHARMS INC | N217026 | March 10, 2023 | RX | SOLUTION | ORAL | 12492167 | July 12, 2042 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
| 5000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | 11827600 | July 12, 2042 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
| 5000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | 12492167 | July 12, 2042 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
| 6000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | 11827600 | July 12, 2042 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
| 6000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | 12492167 | July 12, 2042 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
| 8000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | 11827600 | July 12, 2042 | TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF |
| 8000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | 12492167 | July 12, 2042 | 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 |
| 5000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | March 10, 2028 | NEW CHEMICAL ENTITY |
| 6000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | March 10, 2028 | NEW CHEMICAL ENTITY |
| 8000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | March 10, 2028 | NEW CHEMICAL ENTITY |
| 200MG/ML | DAYBUE | ACADIA PHARMS INC | N217026 | March 10, 2023 | RX | SOLUTION | ORAL | Sept. 10, 2028 | PEDIATRIC EXCLUSIVITY |
| 5000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | Sept. 10, 2028 | PEDIATRIC EXCLUSIVITY |
| 6000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | Sept. 10, 2028 | PEDIATRIC EXCLUSIVITY |
| 8000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | Sept. 10, 2028 | PEDIATRIC EXCLUSIVITY |
| 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 |
| 5000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | March 10, 2030 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 6000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | March 10, 2030 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 8000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | March 10, 2030 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 200MG/ML | DAYBUE | ACADIA PHARMS INC | N217026 | March 10, 2023 | RX | SOLUTION | ORAL | Sept. 10, 2030 | PEDIATRIC EXCLUSIVITY |
| 5000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | Sept. 10, 2030 | PEDIATRIC EXCLUSIVITY |
| 6000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | Sept. 10, 2030 | PEDIATRIC EXCLUSIVITY |
| 8000MG/PACKET | DAYBUE STIX | ACADIA PHARMS INC | N219884 | Dec. 11, 2025 | RX | FOR SOLUTION | ORAL | Sept. 10, 2030 | PEDIATRIC EXCLUSIVITY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| CHEBI:229599 | CHEBI |
| CHEMBL197084 | ChEMBL_ID |
| C000656362 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12482 | IUPHAR_LIGAND_ID |
| DB06045 | DRUGBANK_ID |
| 4042121 | VANDF |
| C4726916 | UMLSCUI |
| 10076 | INN_ID |
| 11318905 | PUBCHEM_CID |
| 365641 | MMSL |
| 41304 | MMSL |
| d10021 | MMSL |
| 019343 | NDDF |
| D12400 | KEGG_DRUG |
| Z2ME8F52QL | UNII |
| 2632852 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Daybue | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63090-660 | SOLUTION | 200 mg | ORAL | NDA | 30 sections |
| Daybue Stix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63090-663 | FOR SOLUTION | 5000 mg | ORAL | NDA | 30 sections |
| Daybue Stix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63090-664 | FOR SOLUTION | 6000 mg | ORAL | NDA | 30 sections |
| Daybue Stix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63090-665 | FOR SOLUTION | 8000 mg | ORAL | NDA | 30 sections |