• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Macrilen (macimorelin)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Macrilen (macimorelin)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Macrilen (macimorelin)  is a growth hormone (GH) secretagogue receptor agonist.

    Macrilen is specifically indicated for the diagnosis of adult growth hormone deficiency.

    Macrilen is supplied as a solution for oral administration. The recommended dose is a single oral dose of 0.5 mg/kg of macimorelin.  The dose is administered as a reconstituted solution.

    Clinical Results

    FDA Approval

    The FDA approval of Macrilen was based on  a randomized, open-label, single-dose, cross-over study in 154 subjects. The objective of the study was to compare the level of agreement between Macrilen test results and insulin tolerance test (ITT) results in adult patients with different pre-test probability of growth hormone deficiency and healthy control subjects. The four groups of individuals evaluated were: Group A:  Adults with a high likelihood of growth hormone deficiency (GHD); Group B:  Adults with an intermediate likelihood of GHD; Group C:  Adults with a low likelihood of GHD and Group D: healthy adults. Overall, Macrilen and the ITT were in complete agreement among 84% of all subjects. Among those with a high likelihood of AGHD prior to testing, Macrilen and the ITT were in complete agreement among 89% of subjects. Macrilen was evaluable in >99% of tests at first try, compared to 83% evaluable with the ITT. Repeatability was observed in 91.2% of the patients (n=34) who underwent two Macrilen tests.

    Side Effects

    Adverse effects associated with the use of Macrilen may include, but are not limited to, the following: 

    • dysgeusia
    • dizziness
    • headache
    • fatigue
    • nausea
    • hunger
    • diarrhea
    • upper respiratory tract infection
    • feeling hot
    • hyperhidrosis
    • nasopharyngitis
    • sinus bradycardia

    Mechanism of Action

    Macrilen (macimorelin)  is a growth hormone (GH) secretagogue receptor agonist. Macimorelin stimulates GH release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus. 
     

    Additional Information

    For additional information regarding Macrilen or growth hormone deficiencies, please visit http://www.strongbridgebio.com/products/macrilen/

    Approval Date: 2017-12-01
    Company Name: Stonebridge Biopharma
    Back to Listings

    Upcoming Events

    • 26Jan

      Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • TechInnovation-360x240.png

      Pace of Technology Innovation in Trials Could Slow After Pandemic Eases

    • AskTheExperts-360x240.png

      Ask the Experts: Certifying and Maintaining Copies of Original Source Documents

    • Resources-360x240.png

      Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

    • FocusinRed-360x240.png

      Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing