Macrilen

(Macimorelin)

Small molecule

AAEterna Zentaris

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Growth1 trial

A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is

Completed·AAEterna Zentaris·Phase 3·NCT04786873·101 enrolled

Growth Hormone Deficiency1 trial

Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency

Completed·AAEterna Zentaris·Phase 3·NCT02558829·157 enrolled

Cachexia1 trial

Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia

Completed·—·Phase 2·NCT01614990·15 enrolled

Regulatory

FDA Approval Timeline[3]

Dec 20, 2017

MACRILEN

NDA NDA205598

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Macimorelin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Macimorelin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA205598). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Macrilen. U.S. Food & Drug Administration.
[5]
SEC EDGAR — AEterna Zentaris company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: AAEterna Zentaris

Patent Landscape[4]

Patent Cliff

Oct 12, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8192719Oct 12, 2027

8192719*PEDApr 12, 2028