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- Macrilen (macimorelin) / AEterna Zentaris
Macimorelin Test: A Safer and Reliable Alternative to the Gold Standard Insulin Tolerance Test (Hall C of the Bella Centre; ePoster) - Apr 10, 2025 - Abstract #ESPEESE2025ESPE_ESE_2209;
- ||||| Macrilen (macimorelin) / AEterna Zentaris
Trial completion: DETECT: A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is (clinicaltrials.gov) - Aug 11, 2024
P3, N=101, Completed, Sponsor: AEterna Zentaris
Active, not recruiting --> Completed
- || Macrilen (macimorelin) / AEterna Zentaris
Review, Journal: New insights on diagnosis and treatment of AVP deficiency. (Pubmed Central) - Jun 8, 2024
In general, treatment of AVP-D focuses on desmopressin substitution, with oral formulations currently showing the best tolerance and safety profile. However, in addition to desmopressin substitution, recent data also showed that psychopathological factors play an important role in managing AVP-D patients.
- |||| Macrilen (macimorelin) / AEterna Zentaris
Enrollment closed, Trial completion date, Trial primary completion date: DETECT: A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is (clinicaltrials.gov) - Apr 23, 2024
P3, N=100, Active, not recruiting, Sponsor: AEterna Zentaris
However, in addition to desmopressin substitution, recent data also showed that psychopathological factors play an important role in managing AVP-D patients. Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> Jun 2024 | Trial primary completion date: Sep 2023 --> Jun 2024
- || Macrilen (macimorelin) / AEterna Zentaris
Review, Journal: Once upon a time: the glucagon stimulation test in diagnosing adult GH deficiency. (Pubmed Central) - Mar 10, 2024
Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> Jun 2024 | Trial primary completion date: Sep 2023 --> Jun 2024 This document provides an update on the utility of GST, summarizes how to perform the test, shows which cut-points should be used in interpreting the results, and discusses its drawbacks and caveats referring to the most recent studies.
- ||||| ponsegromab (PF-06946860) / Pfizer, Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical: 📌 Early trials in #cancercachexia will be discussed by @laird_barry, @JoseMGa95491291 & J. Crawford 👉 #ponsegromab early trial 👉 Multimodal interventions in the #MENAC study 👉 #Macimorelin pilot study Register now: https://t.co/RtasxmTlaZ #SCWD23 #clinicaltrials (Twitter) - May 27, 2023
- | Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Journal: Pilot clinical trial of macimorelin to assess safety and efficacy in patients with cancer cachexia. (Pubmed Central) - Apr 4, 2023
This document provides an update on the utility of GST, summarizes how to perform the test, shows which cut-points should be used in interpreting the results, and discusses its drawbacks and caveats referring to the most recent studies. Daily oral macimorelin for 1
- | Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Journal: Macimorelin Acetate for the Diagnosis of Childhood-onset Growth Hormone Deficiency. (Pubmed Central) - Jan 26, 2023
Despite the widespread use of these tests, various criticisms have been levelled against them, such as the labour-intensive nature of the tests, their potential for serious adverse effects and their questionable reproducibility. Macimorelin acetate, a ghrelin mimetic approved for the diagnosis of adult growth hormone deficiency, could serve an unmet need in the diagnosis of childhood-onset growth hormone deficiency based on its good tolerability and benign side effect profile.
- Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
The effect of glucose dynamics on plasma copeptin levels upon glucagon, arginine, and macimorelin stimulation in healthy adults (Forum 1) - Oct 1, 2022 - Abstract #ENEA2022ENEA_86;
These findings suggest that a drop in glucose levels might be a possible cause for the increase in copeptin levels upon glucagon and arginine stimulation. Whether the drop in glucose levels itself leads to copeptin secretion, or whether it mirrors other stimuli such as hypoglycemia-induced stress cannot be answered with our analysis and should be further investigated.
- || Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
$AEZS Aeterna Zentaris Set to Regain Full Rights to Macrilen™ (Macimorelin) in U.S. and Canada from Novo Nordisk https://t.co/QG2vbW55YB (Twitter) - Aug 29, 2022
- | Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Journal: The effect of glucose dynamics on plasma copeptin levels upon glucagon, arginine, and macimorelin stimulation in healthy adults : Data from: Glucacop, Macicop, and CARGO study. (Pubmed Central) - Aug 6, 2022
A similar course in plasma glucose was observed in the copeptin-stimulating test, i.e., after glucagon and arginine, while macimorelin had no effect on glucose and copeptin levels. We hypothesize that a drop in glucose levels observed upon glucagon and arginine might stimulate copeptin.
- Macrilen (macimorelin) / AEterna Zentaris
Trial completion: Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia (clinicaltrials.gov) - Aug 4, 2022
P2, N=8, Completed, Sponsor: Garcia, Jose M., MD, PhD
We hypothesize that a drop in glucose levels observed upon glucagon and arginine might stimulate copeptin. Active, not recruiting --> Completed
- ||| Macrilen (macimorelin) / AEterna Zentaris
Trial completion date, Trial primary completion date: DETECT: A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is (clinicaltrials.gov) - Jul 27, 2022
P3, N=100, Recruiting, Sponsor: AEterna Zentaris
Active, not recruiting --> Completed Trial completion date: Jul 2022 --> Sep 2023 | Trial primary completion date: Jul 2022 --> Sep 2023
- || Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical, PK/PD data, Journal: Safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin in children with suspected growth hormone deficiency: An open-label, group comparison, dose escalation trial. (Pubmed Central) - Apr 1, 2022
P2
All 3 doses of macimorelin had excellent safety and tolerability with PK/PD profiles in expected ranges. These results support the use of 1.0 mg/mL macimorelin in a Phase 3 test validation trial in children.
- Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Budget Impact Analysis of Macimorelin, an Oral Growth Hormone Stimulation Test, As a Diagnostic Test for Adult Growth Hormone Deficiency (AGHD) across 5 European Countries (In-person & Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_1738;
The macimorelin test is also associated with fewer adverse events, leading to a potentially better patient experience. Finally, macimorelin test requires less clinical staff time and may ultimately increase hospital capacity through efficient resource utilisation.
- || Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical, Journal: Thorough QT/QTc Study Evaluating the Effect of Macimorelin on Cardiac Safety Parameters in Healthy Participants. (Pubmed Central) - Jan 19, 2022
Macimorelin did not raise other safety concerns and was well tolerated. In summary, a single supratherapeutic dose of macimorelin prolonged cardiac repolarization according to the regulatory guideline.
- || Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical, Review, Journal: Current concepts of the diagnosis of adult growth hormone deficiency. (Pubmed Central) - Dec 16, 2021
Patients with a peak GH level that is below a predetermined cutpoint are classified as GH deficient. A systematic approach to the diagnosis of GH deficiency is essential in order to accurately identify adults who may benefit from GH replacement.
- || Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical, Journal: Effects of oral macimorelin on copeptin and anterior pituitary hormones in healthy volunteers. (Pubmed Central) - Dec 16, 2021
P=N/A
However, macimorelin did not stimulate copeptin and therefore does not provide an oral test alternative for the diagnosis of diabetes insipidus. Additionally, a stimulatory effect was seen for prolactin and fT4, but not for ACTH and gonadotropic hormones.
- | Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Journal: Translational potential of the ghrelin receptor agonist macimorelin for seizure suppression in pharmacoresistant epilepsy. (Pubmed Central) - Oct 22, 2021
While the full ghrelin-R agonist macimorelin was not significantly antiepileptogenic nor disease-modifying, this is the first study to demonstrate its anticonvulsant effects in the IHKA model of drug-refractory temporal lobe epilepsy. These findings highlight the potential use of macimorelin as a novel treatment option for seizure suppression in pharmacoresistant epilepsy.
- || Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical, Review, Journal: Growth hormone deficiency in adults with Cushing's disease. (Pubmed Central) - Sep 22, 2021
Growth hormone replacement may improve body composition, bone density, linear growth (in children), exercise capacity, dyslipidemia and quality of life. While generally safe, GH replacement requires careful monitoring to assure effectiveness and tolerance in treated patients.
- |||| Macrilen (macimorelin) / AEterna Zentaris
Enrollment open, Trial initiation date: DETECT: A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is (clinicaltrials.gov) - Sep 16, 2021
P3, N=100, Recruiting, Sponsor: AEterna Zentaris
While generally safe, GH replacement requires careful monitoring to assure effectiveness and tolerance in treated patients. Not yet recruiting --> Recruiting | Initiation date: Apr 2021 --> Sep 2021
- || Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical, Journal: Current aspects of diagnosis and treatment of adult GH-deficiency (Pubmed Central) - Aug 27, 2021
Moreover, in 2017 FDA approved the use of macimorelin (oral GH secretagogue) for the diagnosis of AGHD...Published data on GH receptor polymorphism associations with treatment efficacy remains controversial. Development of long-acting GH formulations is a currect perspective for the increase of treatment compliance.
- || Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical, Journal: Oxytocin levels in response to pituitary provocation tests in healthy volunteers. (Pubmed Central) - Aug 20, 2021
Neither the arginine infusion nor the oral macimorelin test stimulate plasma oxytocin levels, whereas there was an increase with high variance upon hypertonic saline infusion. As a predictable rise in most participants is required for a reliable pituitary provocation test, none of the investigated pituitary provocation tests can be recommended diagnostically to identify patients with an oxytocin deficiency.
- |||||||| Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
New P3 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 (EUDRACT) - Aug 7, 2021
P3, N=100, , Sponsor: Aeterna Zentaris GmbH
- || Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical, PK/PD data, Journal: Safety, tolerability, pharmacokinetics, and pharmacodynamics of macimorelin in healthy adults: Results of a single-dose, randomized controlled study. (Pubmed Central) - Jul 7, 2021
Macimorelin exposure was less than dose-proportional over the dose range studied. Administration of macimorelin stimulated GH production, with the greatest increases observed in the macimorelin 0.5- and 1.0-mg/kg groups.
- | Journal: Generative network complex for the automated generation of druglike molecules. (Pubmed Central) - Jun 22, 2021
To further validate the reliability of the predictions, these molecules are reevaluated and screened by independent 2D fingerprint-based predictors to come up with a few hundreds of new drug candidates. As a demonstration, we apply our GNC to generate a large number of new BACE1 inhibitors, as well as thousands of novel alternative drug candidates for eight existing market drugs, including Ceritinib, Ribociclib, Acalabrutinib, Idelalisib, Dabrafenib, Macimorelin, Enzalutamide, and Panobinostat.
- | Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Journal: Comprehensive insights into the formation of metabolites of the ghrelin mimetics capromorelin, macimorelin and tabimorelin as potential markers for doping control purposes. (Pubmed Central) - May 22, 2021
Further, the intact drugs were implemented into World Anti-Doping Agency (WADA)-compliant initial testing (LOD: 0.02-0.60 ng/mL) and confirmation procedures (LOI: 0.18-0.89 ng/mL) for human urine and blood matrices. The obtained results allow extending the test spectrum of doping agents in multi-target screening assays for growth hormone-releasing factors from human urine.
- |||||||| Macrilen (macimorelin) / AEterna Zentaris
New P3 trial: DETECT: A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is (clinicaltrials.gov) - Mar 7, 2021
P3, N=100, Not yet recruiting, Sponsor: AEterna Zentaris
- Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
[VIRTUAL] Pharmacokinetics and Pharmacodynamics of Macimorelin Acetate (AEZS-130) in Paediatric Patients With Suspected Growth Hormone Deficiency (GHD) (On-Demand) - Feb 2, 2021 - Abstract #ENDO2021ENDO_1616;
For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
- Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
[VIRTUAL] Oxytocin Levels in Response to Pituitary Provocation Tests in Healthy Volunteers (On-Demand) - Feb 2, 2021 - Abstract #ENDO2021ENDO_1357;
Further research will be important to determine whether this test could be used diagnostically to identify patients with oxytocin deficiency. In contrast to animal data, arginine and macimorelin did not stimulate oxytocin.
- Macrilen (macimorelin) / AEterna Zentaris
Trial completion date: Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia (clinicaltrials.gov) - Feb 2, 2021
P2, N=8, Active, not recruiting, Sponsor: Garcia, Jose M., MD, PhD
In contrast to animal data, arginine and macimorelin did not stimulate oxytocin. Trial completion date: Dec 2020 --> Dec 2021
- | Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Journal: Sensitivity and specificity of the macimorelin test for diagnosis of AGHD. (Pubmed Central) - Dec 17, 2020
Macimorelin performance was not meaningfully affected by age, BMI, or sex, indicating robustness for AGHD diagnosis. Of the 4 GH cutpoints evaluated, the cutpoint of 5.1 ng/mL provided maximal specificity (96%) and high sensitivity (92%) and was in good overall agreement with the ITT at the same cutpoint (87%).
- || Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical, Journal: Adult growth hormone deficiency: clinical advances and approaches to improve adherence. (Pubmed Central) - Jun 19, 2020
We reviewed the data of the oral macimorelin test compared to the GHRH plus arginine and the insulin tolerance tests that led to its approval by the United States FDA and European Medicines Agency for adult diagnostic testing...We identify that non-adherence and discontinuation rates are high and recommend strategies to support patients to improve adherence. We also provide an overview of several long-acting GH (LAGH) preparations currently under development and their potential role in improving treatment adherence.Expert opinion: This article summarizes recent clinical advances in rhGH replacement therapy, the biological and molecular aspects that may influence rhGH action, and offers practical strategies to enhance adherence in adults with GHD.
- ||| Macrilen (macimorelin) / AEterna Zentaris, Novo Nordisk
Clinical: $AEZS Announces Completion of Patient Recruitment in Dose-Finding Pediatric Study of Macimorelin. Data Q2'20. (Twitter) - Jan 28, 2020
- Macrilen (macimorelin) / AEterna Zentaris
Enrollment closed, Trial primary completion date: Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia (clinicaltrials.gov) - Jan 7, 2020
P2, N=8, Active, not recruiting, Sponsor: Garcia, Jose M., MD, PhD
We also provide an overview of several long-acting GH (LAGH) preparations currently under development and their potential role in improving treatment adherence.Expert opinion: This article summarizes recent clinical advances in rhGH replacement therapy, the biological and molecular aspects that may influence rhGH action, and offers practical strategies to enhance adherence in adults with GHD. Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2019 --> Jul 2020
- | Macrilen (macimorelin) / AEterna Zentaris
Trial completion: Macicop: Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers (clinicaltrials.gov) - Aug 7, 2019
P=N/A, N=28, Completed, Sponsor: University Hospital, Basel, Switzerland
Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2019 --> Jul 2020 Recruiting --> Completed
- || Macrilen (macimorelin) / AEterna Zentaris, Novartis
FDA event: @novonordiskus do you have a service locator to help consumers find Medical Professionals in the United States who administer the FDA Approved #Macrilen GHD test? (Twitter) - Jul 30, 2019
- | Macrilen (macimorelin) / AEterna Zentaris
Trial primary completion date: Macicop: Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers (clinicaltrials.gov) - May 8, 2019
P=N/A, N=28, Recruiting, Sponsor: University Hospital, Basel, Switzerland
Recruiting --> Completed Trial primary completion date: Apr 2019 --> Aug 2019
- | Macrilen (macimorelin) / AEterna Zentaris
Trial completion date: Macicop: Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers (clinicaltrials.gov) - Mar 16, 2019
P=N/A, N=28, Recruiting, Sponsor: University Hospital, Basel, Switzerland
Trial primary completion date: Apr 2019 --> Aug 2019 Trial completion date: Apr 2019 --> Aug 2019
- | Macrilen (macimorelin) / AEterna Zentaris
New trial: Macicop: Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers (clinicaltrials.gov) - Feb 18, 2019
P=N/A, N=30, Recruiting, Sponsor: University Hospital, Basel, Switzerland
- || Macrilen (macimorelin) / AEterna Zentaris
New P2 trial: A clinical study with macimorelin acetate comparing three doses in their safety and tolerability in children with suspected growth hormone deficiency (GHD) (EUDRACT) - Nov 23, 2018
P2, N=24, Ongoing, Sponsor: Aeterna Zentaris GmbH
- Macrilen (macimorelin) / AEterna Zentaris
Trial completion date, Trial primary completion date: Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia (clinicaltrials.gov) - Aug 6, 2018
P2, N=8, Recruiting, Sponsor: Garcia, Jose M., MD, PhD
Trial completion date: Apr 2019 --> Aug 2019 Trial completion date: Dec 2017 --> Dec 2020 | Trial primary completion date: Dec 2017 --> Jul 2019
- ||||| Macrilen (macimorelin) / AEterna Zentaris
Trial initiation date: Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency (clinicaltrials.gov) - Feb 9, 2018
P3, N=157, Completed, Sponsor: AEterna Zentaris
Trial completion date: Dec 2017 --> Dec 2020 | Trial primary completion date: Dec 2017 --> Jul 2019 Initiation date: Sep 2015 --> Dec 2015
- Macrilen (macimorelin) / AEterna Zentaris
Enrollment change, Trial primary completion date: Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia (clinicaltrials.gov) - May 3, 2017
P2, N=8, Recruiting, Sponsor: Garcia, Jose M., MD, PhD
Initiation date: Sep 2015 --> Dec 2015 N=26 --> 8 | Trial primary completion date: Aug 2017 --> Dec 2017
- ||||||| Macrilen (macimorelin) / AEterna Zentaris
Trial completion, Enrollment change: Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency (clinicaltrials.gov) - Feb 13, 2017
P3, N=157, Completed, Sponsor: AEterna Zentaris
N=26 --> 8 | Trial primary completion date: Aug 2017 --> Dec 2017 Active, not recruiting --> Completed | N=110 --> 157
- ||||| Macrilen (macimorelin) / AEterna Zentaris
Enrollment closed: Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency (clinicaltrials.gov) - Nov 21, 2016
P3, N=110, Active, not recruiting, Sponsor: AEterna Zentaris
Active, not recruiting --> Completed | N=110 --> 157 Recruiting --> Active, not recruiting
- Macrilen (macimorelin) / AEterna Zentaris
Trial primary completion date: Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia (clinicaltrials.gov) - Aug 10, 2016
P2, N=26, Recruiting, Sponsor: Garcia, Jose M., MD, PhD
Recruiting --> Active, not recruiting Trial primary completion date: Aug 2016 --> Aug 2017
- |||||| Macrilen (macimorelin) / AEterna Zentaris
Enrollment open: Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency (clinicaltrials.gov) - Oct 23, 2015
P3, N=110, Recruiting, Sponsor: AEterna Zentaris
Trial primary completion date: Aug 2016 --> Aug 2017 Not yet recruiting --> Recruiting
- |||||||||| Macrilen (macimorelin) / AEterna Zentaris
New P3 trial: Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency (clinicaltrials.gov) - Sep 24, 2015
P3, N=110, Not yet recruiting, Sponsor: AEterna Zentaris
- Macrilen (macimorelin) / AEterna Zentaris
Trial primary completion date: Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia (clinicaltrials.gov) - Mar 10, 2015
P2, N=26, Recruiting, Sponsor: Garcia, Jose M., MD, PhD
Not yet recruiting --> Recruiting Trial primary completion date: Aug 2014 --> Aug 2016