TheraRadar
Data updated: May 26, 2026

MACRILEN (macimorelin acetate)

First-in-Class Orphan Drug
Endocrine Approved 2017-12-20
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2017-12-20
Patent Cliff
2027

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
FOR SOLUTION

Companies

AETERNA ZENTARIS
Active Ingredient: MACIMORELIN ACETATE

MACRILEN Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2017 to 2019
Nov 2019 SUPPL
Label · Labeling
FDA Letter
Dec 2017 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What MACRILEN Treats

1 FDA approvals

Originally approved for its first indication in 2017 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MACRILEN FDA Label Details

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1 OB patents · 1 families · 14 international docs across 11 countries

MACRILEN Patents & Exclusivity

Latest Patent: Oct 2027

Patents (1 active)

US8192719 Expires Oct 12, 2027
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2027
  • • 1 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA205598 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.