| Stem definition | Drug id | CAS RN |
|---|---|---|
| 1311 | 56-85-9 |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 10, 2004 | FDA | EMMAUS MEDCL |
| 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 |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 73.52 | 22.39 | 18 | 1177 | 5985 | 63481842 |
| 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 |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 149.04 | 29.71 | 30 | 649 | 4023 | 34952229 |
| Tendon calcification | 52.38 | 29.71 | 7 | 672 | 68 | 34956184 |
| Acute chest syndrome | 48.03 | 29.71 | 9 | 670 | 818 | 34955434 |
| Blood parathyroid hormone increased | 31.37 | 29.71 | 7 | 672 | 1507 | 34954745 |
| 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 |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 182.65 | 21.43 | 40 | 1526 | 7882 | 79734940 |
| Tendon calcification | 47.16 | 21.43 | 7 | 1559 | 149 | 79742673 |
| Acute chest syndrome | 42.20 | 21.43 | 9 | 1557 | 1552 | 79741270 |
| Blood parathyroid hormone increased | 25.56 | 21.43 | 7 | 1559 | 3438 | 79739384 |
| Tendon rupture | 23.95 | 21.43 | 9 | 1557 | 12117 | 79730705 |
None
| Source | Code | Description |
|---|---|---|
| ATC | A16AA03 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Amino acids and derivatives |
| FDA CS | M0000922 | Amino Acids |
| FDA EPC | N0000175780 | Amino Acid |
| CHEBI has role | CHEBI:27027 | trace elements |
| CHEBI has role | CHEBI:50733 | Dietary Supplement |
| CHEBI has role | CHEBI:61908 | nitric oxide synthase inhibitors |
| CHEBI has role | CHEBI:75771 | Mus musculus metabolites |
| CHEBI has role | CHEBI:75772 | S. cerevisiae metabolites |
| CHEBI has role | CHEBI:76971 | Escherichia coli metabolites |
| CHEBI has role | CHEBI:77746 | Homo sapiens metabolite |
| CHEBI has role | CHEBI:78675 | fundamental metabolites |
| CHEBI has role | CHEBI:25212 | metabolites |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Short bowel syndrome | indication | 26629001 | DOID:10605 |
| Hb SS disease | symptomatic treatment | 127040003 | DOID:10923 |
None
None
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 2.17 | acidic |
| pKa2 | 12.12 | acidic |
| pKa3 | 9.22 | Basic |
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 5GM/PACKET | ENDARI | EMMAUS MEDCL | N208587 | July 7, 2017 | RX | FOR SOLUTION | ORAL | July 7, 2024 | TO REDUCE THE ACUTE COMPLICATIONS OF SICKLE CELL DISEASE IN ADULT AND PEDIATRIC PATIENTS 5 YEARS OF AGE AND OLDER. |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Amino acid transporter | Transporter | IC50 | 4.57 | CHEMBL |
| ID | Source |
|---|---|
| 4027901 | VUID |
| N0000177918 | NUI |
| 4025874 | VANDF |
| 4027901 | VANDF |
| C0017797 | UMLSCUI |
| CHEBI:28300 | CHEBI |
| GLN | PDB_CHEM_ID |
| CHEMBL930 | ChEMBL_ID |
| DB00130 | DRUGBANK_ID |
| D005973 | MESH_DESCRIPTOR_UI |
| 5961 | PUBCHEM_CID |
| 1413 | INN_ID |
| 723 | IUPHAR_LIGAND_ID |
| 0RH81L854J | UNII |
| 4885 | RXNORM |
| 12067 | MMSL |
| 158599 | MMSL |
| 158601 | MMSL |
| d07315 | MMSL |
| 000928 | NDDF |
| 25761002 | SNOMEDCT_US |
| 412421007 | SNOMEDCT_US |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Endari | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42457-420 | POWDER, FOR SOLUTION | 5 g | ORAL | NDA | 26 sections |
| Endari | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42457-420 | POWDER, FOR SOLUTION | 5 g | ORAL | NDA | 26 sections |