macimorelin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
growth hormone release-stimulating peptides 5271 381231-18-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • macimorelin
  • macimorelin acetate
  • D-87575
  • EP1572
  • ARD 07
Macimorelin stimulates GH release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus.
  • Molecular weight: 474.57
  • Formula: C26H30N6O3
  • CLOGP: 1.60
  • LIPINSKI: 1
  • HAC: 9
  • HDO: 6
  • TPSA: 144.90
  • ALOGS: -4.90
  • ROTB: 9

  • Status: OFM

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
Adult growth hormone deficiency diagnosis 421684006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Growth hormone secretagogue receptor type 1 GPCR AGONIST IC50 7.81 IUPHAR DRUG LABEL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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