macimorelin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| growth hormone release-stimulating peptides | 5271 | 381231-18-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Macimorelin stimulates GH release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 11, 2019 | EMA | AETERNA ZENTARIS GMBH | |
| Dec. 20, 2017 | FDA | AETERNA ZENTARIS GMBH |
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 |
|---|---|---|
| ATC | V04CD06 | VARIOUS DIAGNOSTIC AGENTS OTHER DIAGNOSTIC AGENTS Tests for pituitary function |
| FDA EPC | N0000193785 | Growth Hormone Secretagogue Receptor Agonist |
| FDA MoA | N0000193786 | Growth Hormone Secretagogue Receptor Agonists |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Adult growth hormone deficiency | diagnosis | 421684006 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 12.35 | acidic |
| pKa2 | 13.06 | acidic |
| pKa3 | 13.84 | acidic |
| pKa4 | 7.93 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 60MG BASE/POUCH | MACRILEN | NOVO | N205598 | Dec. 20, 2017 | DISCN | FOR SOLUTION | ORAL | 8192719 | Oct. 12, 2027 | A METHOD FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY BY MEASURING THE LEVEL OF GROWTH HORMONE AFTER ORAL ADMINISTRATION OF MACIMORELIN |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 60MG BASE/POUCH | MACRILEN | NOVO | N205598 | Dec. 20, 2017 | DISCN | FOR SOLUTION | ORAL | Dec. 20, 2024 | FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Growth hormone secretagogue receptor type 1 | GPCR | AGONIST | IC50 | 7.81 | IUPHAR | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 8680B21W73 | UNII |
| 945212-59-9 | SECONDARY_CAS_RN |
| C2986922 | UMLSCUI |
| CHEMBL278623 | ChEMBL_ID |
| 9804938 | PUBCHEM_CID |
| DB13074 | DRUGBANK_ID |
| CHEMBL2364617 | ChEMBL_ID |
| D10563 | KEGG_DRUG |
| 9073 | INN_ID |
| 9745 | IUPHAR_LIGAND_ID |
| 33368 | MMSL |
| d08694 | MMSL |
| 017443 | NDDF |
| 017444 | NDDF |
| 781246008 | SNOMEDCT_US |
| 781247004 | SNOMEDCT_US |
| 781266004 | SNOMEDCT_US |
| 4037714 | VANDF |
| 1999419 | RXNORM |
| C582727 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Macrilen | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0169-1401 | GRANULE, FOR SOLUTION | 60 mg | ORAL | NDA | 25 sections |
| Macrilen | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71090-002 | GRANULE, FOR SOLUTION | 60 mg | ORAL | NDA | 25 sections |