Drugs / Macimorelin
Macimorelin
also known as
AEZS-130 · ARD-07 · ARD-07 ACETATE · D-87575 · D-87575 ACETATE · EP 1572 · EP-1572 ACETATE · EP01572 · +7 more
Small molecule targets GHSR via activation
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | MACRILEN | — | 2026-07-23 | fda.gov ↗ |
| Approved | EU (EMA) | Ghryvelin (previously Macimorelin Aeterna Zentaris) | — | 2019-01-11 | europa.eu ↗ |
| Approved | US (FDA) | MACRILEN | — | 2017-12-20 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00377377 | Nov 2005 → Jul 2006 | — | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02558829 | Dec 2015 → Nov 2016 | hypopituitarism | AEterna Zentaris | Completed | Mixed |
| Phase 3 | NCT00448747 | Jun 2007 → Jul 2011 | pituitary deficiency | AEterna Zentaris | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03844217 | Mar → Jul 2019 | — | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT01614990 Comparator | May 2012 → Jul 2020 | — | Garcia, Jose M., MD, PhD | Completed | No outcome recorded |
| Phase 3 | NCT04786873 Comparator | Nov 2021 → Jun 2024 | pituitary deficiency | AEterna Zentaris | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-10-31 | Novo Nordisk A/S | Novo Nordisk udvider sin biopharm-forretning med køb af de amerikanske og canadiske rettigheder til Macrilen(TM) novonordisk.com ↗ |
| 2018-10-31 | Novo Nordisk A/S | Novo Nordisk expands its biopharm business with the acquisition of the US and Canadian rights to Macrilen(TM) novonordisk.com ↗ |
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Macimorelin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01614990 ↗ |
| Known as | AEZS-130 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00448747 ↗ |
| Known as | ARD-07 | “AEZS-130 (formerly ARD-07)” NCT00448747 ↗ |
| Known as | ARD-07 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | D-87575 | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | D-87575 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | EP 1572 | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | EP-1572 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | EP01572 | “An oral formulation of EP01572, a peptidomimetic growth hormone secretagogue, was studied.” PMID 17284637 ↗ Feb 2007 |
| Known as | Ghryvelin (previously macimorelin aeterna zentaris) | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | JMV 1843 | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | MACIMORELIN ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | Macimorelina | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | Macimoreline | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | Macrilen | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Known as | Solorel | ChEMBL registry synonym — accepted as the source's own label CHEMBL278623 ↗ |
| Action | Activate | “An oral delivery system would be preferable in many of the possible therapeutic indications of ghrelin agonists such as EP01572.” PMID 17284637 ↗ Feb 20071“Ghrelin receptor agonist” CHEMBL278623 ↗ |
| Modality | Small molecule | — CHEMBL278623 ↗ |
| Route | Oral | “EP01572 was given orally to 36 male subjects” PMID 17284637 ↗ Feb 2007 |
| Target | GHSR | “Ghrelin receptor agonist” CHEMBL278623 ↗ |