Macimorelin - PharmaKB

Macrilen, Ghryvelin (previously macimorelin aeterna zentaris)(macimorelin)

Ghryvelin, Macimorelin, Macrilen (macimorelin) is a small molecule pharmaceutical. Macimorelin was first approved as Macrilen on 2017-12-20. It has been approved in Europe to treat endocrine diagnostic techniques. The pharmaceutical is active against growth hormone secretagogue receptor type 1.

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Events

FDA approval date

EMA approval date

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Study first post date

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Therapeutic Areas

Therapeutic Area	MeSH
diagnosis	D003933

Trade Name

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EMA

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Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Macimorelin acetate

Tradename	Company	Number	Date	Products
MACRILEN	Novo Nordisk	N-205598 DISCN	2017-12-20	1 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
macrilen	New Drug Application	2023-11-27

Indications

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Agency Specific

FDA

EMA

Expiration	Code
MACIMORELIN ACETATE, MACRILEN, NOVO
2024-12-20	ODE-170

Patent Expiration

Patent	Expires	Flag	FDA Information
Macimorelin Acetate, Macrilen, Novo
8192719	2027-10-12		U-2220

ATC Codes

V: Various drug classes in atc

— V04: Diagnostic agents

— V04C: Other diagnostic agents in atc

— V04CD: Pituitary function test diagnostic agents

— V04CD06: Macimorelin

HCPCS

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Clinical

Clinical Trials

6 clinical trials

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Indications Phases 4

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Laron syndrome	D046150	Orphanet_633	E34.321	—	—	3	—	—	3
Endocrine system diseases	D004700	EFO_0001379	E34.9	—	—	2	—	—	2
Pituitary dwarfism	D004393	EFO_1001109	E23.0	—	—	2	—	—	2

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Wasting syndrome	D019282	—	—	—	1	—	—	—	1
Cachexia	D002100	HP_0004326	R64	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Diabetes insipidus	D003919	—	E23.2	—	—	—	—	1	1
Polyuria	D011141	HP_0000103	R35	—	—	—	—	1	1
Polydipsia	D059606	HP_0001959	R63.1	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Macimorelin
INN	macimorelin
Description	Macimorelin (INN) – or Macrilen (trade name) – is a drug that was developed by Æterna Zentaris for use in the diagnosis of adult growth hormone deficiency. Macimorelin acetate, the salt formulation, is a synthetic growth hormone secretagogue receptor agonist. It is a growth hormone secretagogue receptor (ghrelin receptor) agonist, causing release of growth hormone from the pituitary gland. Macimorelin acetate is described chemically as D-Tryptophanamide, 2-methylalanyl-N-[(1R)-1-(formylamino)-2-(1H-indol-3-yl)ethyl]-acetate.
Classification	Small molecule
Drug class	prehormones or hormone-release stimulating peptides: growth hormone-release stimulating peptides
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)(N)C(=O)N[C@H](Cc1c[nH]c2ccccc12)C(=O)N[C@H](Cc1c[nH]c2ccccc12)NC=O