Drugs / Orticumab
Orticumab
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01486823 | Nov 2011 → Jul 2012 | — | BioInvent International AB | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01258907 | Mar 2010 → Jul 2012 | atherosclerosis | Genentech, Inc. | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT06927739 Comparator | Aug 2025 → Feb 2027 expected | acute coronary syndrome, coronary atherosclerosis, myocardial infarction | Abcentra | Recruiting | No outcome recorded |
| Phase 2 | NCT04776629 Comparator | Jun 2021 → Nov 2022 | coronary artery disorder, metabolic syndrome X, psoriasis | Abcentra | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2012-07-11 | BioInvent International AB | Results Announcement of topline results from the GLACIER study bioinvent.com ↗
No statistically significant reduction between placebo and the two active treatment arms was observed. |
| 2010-11-10 | BioInvent International AB | Regulatory BioInvent announces approval to start Phase II trial for its novel cardiovascular drug BI-204 bioinvent.com ↗
Lund, Sweden - 10 November 2010 - BioInvent International AB (OMXS: BINV) today announces IND clearance from the U.S. Food & Drug Administration (FDA) to initiate a Phase II study for BI-204. |
| 2009-05-06 | BioInvent International AB | Results BioInvent Reports Positive Phase I Results for BI-204, in development for prevention of cardiovascular conditions associated with atherosclerosis bioinvent.com ↗
BioInvent International AB (OMXS:BINV) today announces that its therapeutic antibody product candidate BI-204 (anti-oxLDL), has reached the primary endpoint in its Phase I trial, and was safe and well tolerated. |
| 2008-01-15 | BioInvent International AB | Regulatory BioInvent and Genentech Initiate Phase I Clinical Trial for BI-204, a potential treatment for cardiovascular conditions associated with atherosclerosis. bioinvent.com ↗
BioInvent International AB (OMXS: BINV) announced today that they have received approval from the Danish Medicines Agency to initiate a Phase I clinical trial of BI-204, a potential treatment for cardiovascular conditions brought on by atherosclerosis. |
All press releases naming this drug 10 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Orticumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04776629 ↗ |
| Known as | BI-204 | “This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on...” NCT01258907 ↗1“MLDL1278A (also known as BI-204).” NCT01486823 ↗ |
| Known as | MLDL1278A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01258907 ↗ |
| Known as | RG-7418 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2109533 ↗ |
| Action | Inhibit | “Inhibition of oxidized low-density lipoprotein with orticumab” PMID 38523341 ↗ May 2024 |
| Modality | Protein / enzyme biologic | “by Exposure to a Recombinant Antibody” NCT01258907 ↗ |
| Route | Intravenous | “Single intravenous dose” NCT01258907 ↗ |