Macrilen

(Macimorelin)

Phase 3Small molecule

AAEterna Zentaris

Macrilen is one of 83 small molecule programs targeting Cachexia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

CachexiaActive, not recruiting

Growth Hormone DeficiencyActive, not recruiting

GrowthActive, not recruiting

CachexiaPhase 2

Active, not recruiting

Growth Hormone DeficiencyPhase 3

Active, not recruiting

GrowthPhase 3

Active, not recruiting

Competition

Competitive Landscape

364 competitors in Growth

#DrugCompanyPhaseTrials

Macrilen

AAEterna Zentaris

Phase 3

1 2

Lovenox

Sanofi

Preclinical

2 3

Aricept

Eisai

Preclinical

1 4

Zyloprim

Alnylam Pharmaceuticals

Preclinical

1 5

Somavaratan

Glucophage

2 7

Trental

VValidus Pharmaceuticals

Preclinical

1 8

Alli

EEngelhard Arzneimittel GmbH & Co.KG

Preclinical

1 9

Glucagon

XXeris Pharmaceuticals

Preclinical

1 10

CRYSVITA

Kyowa Kirin Co., Ltd.

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

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

Growth Hormone Deficiency1 trial

Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency

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

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

Regulatory

FDA Approval Timeline[4]

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]
Open Targets Platform — Drug–disease associations for Macimorelin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA205598). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Macrilen. U.S. Food & Drug Administration.
[6]
SEC EDGAR — AEterna Zentaris company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAEterna Zentaris

Patent Landscape[5]

Patent Cliff

Oct 12, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8192719Oct 12, 2027

8192719*PEDApr 12, 2028

Macrilen

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Cachexia1 trial

Growth Hormone Deficiency1 trial

Growth1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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