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levacetylleucine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5858 | 1188-21-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Levacetylleucine is the L-enantiomer of acetyl-DL-leucine, an orally administered modified amino acid. It is thought to improve neuronal and cellular metabolism by enhancing mitochondrial function and energy homeostasis. Levacetylleucine is approved for the treatment of Niemann–Pick disease type C, where it helps improve neurological manifestations such as gait impairment, coordination, and fine motor function.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 24, 2024 | FDA | IntraBio |
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 |
|---|---|---|---|---|---|---|
| Off label use | 169.98 | 129.59 | 44 | 9 | 1102208 | 89526186 |
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 |
|---|---|---|---|---|---|---|
| Off label use | 335.14 | 187.75 | 90 | 20 | 1500095 | 109089094 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N07XX27 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000190110 | Organic Anion Transporter 1 Inhibitors |
| FDA MoA | N0000190111 | Organic Anion Transporter 3 Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| CHEBI has role | CHEBI:25212 | metabolite |
| FDA MoA | N0000193845 | Bile Salt Export Pump Inhibitors |
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 |
|---|---|---|---|
| Niemann-Pick disease, type C | indication | 66751000 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 1GM/PACKET | AQNEURSA | INTRABIO | N219132 | Sept. 24, 2024 | RX | FOR SUSPENSION | ORAL | 11400067 | April 19, 2037 | USE OF LEVACETYLLEUCINE FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE-C (NPC) |
| 1GM/PACKET | AQNEURSA | INTRABIO | N219132 | Sept. 24, 2024 | RX | FOR SUSPENSION | ORAL | 12433862 | April 19, 2037 | TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE-C (NPC) FOR A DURATION OF GREATER THAN 3 MONTHS |
| 1GM/PACKET | AQNEURSA | INTRABIO | N219132 | Sept. 24, 2024 | RX | FOR SUSPENSION | ORAL | 12433863 | April 19, 2037 | TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE-C (NPC) FOR A DURATION OF AT LEAST ABOUT 3 MONTHS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1GM/PACKET | AQNEURSA | INTRABIO | N219132 | Sept. 24, 2024 | RX | FOR SUSPENSION | ORAL | Sept. 24, 2029 | NEW CHEMICAL ENTITY |
| 1GM/PACKET | AQNEURSA | INTRABIO | N219132 | Sept. 24, 2024 | RX | FOR SUSPENSION | ORAL | Sept. 24, 2031 | TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULTS AND PEDIATRIC PATIENTS WEIGHING GREATER THAN OR EQUAL TO 15 KG |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| LAY | PDB_CHEM_ID |
| CHEMBL56021 | ChEMBL_ID |
| C000731246 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB16956 | DRUGBANK_ID |
| 4043428 | VANDF |
| C4547971 | UMLSCUI |
| 13104 | INN_ID |
| 70912 | PUBCHEM_CID |
| E915HL7K2O | UNII |
| 2375522 | RXNORM |
| D12967 | KEGG_DRUG |
| 389496 | MMSL |
| 43224 | MMSL |
| d10224 | MMSL |
| 019864 | NDDF |
| CHEBI:17786 | CHEBI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| AQNEURSA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 83853-101 | GRANULE, FOR SUSPENSION | 1000 mg | ORAL | NDA | 27 sections |