Rare diseases
Investigational molecules
Locations
Orticumab is a human monoclonal antibody — a protein made by the immune system that has been designed in the laboratory to bind to a specific target. It is being developed by the US biopharmaceutical company Abcentra as an anti-inflammatory treatment for heart inflammation.[4] The antibody is also known by the development codes 2D03, BI-204, MLDL-1278A and RG-7418.[2] Orticumab is not yet an authorised medicine; it remains an investigational substance under evaluation in clinical trials.
Orticumab is a human monoclonal antibody, which means it is a laboratory-made protein that mimics the antibodies naturally produced by the immune system. It has been designed to act as an anti-inflammatory treatment for heart inflammation.[4] The substance is classified as an anti-inflammatory, an antibody, and a monoclonal antibody; it is also described as an antihyperlipidaemic and an immunomodulator.[2] Orticumab has been developed under several names: 2D03, Anti-oxLDL, BI-204, MLDL-1278A and RG-7418.[2] It was originally discovered by BioInvent International and has been developed by Abcentra, BioInvent International and Genentech.[2]
Orticumab works by binding to oxidized low-density lipoprotein (LDL), a harmful form of cholesterol that promotes inflammation in the walls of the arteries.[4] Oxidized LDL is widely recognised as a key factor in atherosclerotic plaque inflammation and instability, which contributes to the risk of a recurrent heart attack in people who have survived a myocardial infarction.[5] By targeting oxidized LDL directly, orticumab aims to reduce coronary inflammation. Its mechanism of action is described as immunomodulation and LDL receptor antagonism.[2]
Orticumab is being studied for conditions related to inflammation in the coronary arteries. The conditions named in the clinical trial records and study information include:
Orticumab is given by injection. In the FORTIFY trial, the intervention is recorded as an injection, with the dose reported as 00 milligram(s), meaning the specific dose has not been published in the registry record.[1] The trial also includes a placebo arm, in which participants receive a matching injection that contains no active substance.[1]
The clinical development of orticumab currently centres on one registered trial: the FORTIFY study.[1] FORTIFY — which stands for Focused orticumab Research for Treating inflammation in Coronary Arteries — is a Phase 2, double-blind, randomised, placebo-controlled trial.[4] It is designed to determine the clinical effect of orticumab on inflammation in people who have had a previous myocardial infarction and who have elevated coronary inflammation based on the pericoronary Fat Attenuation Index (FAI) measured during a coronary computed tomography angiography (CCTA), a heart CT scan.[1][4]
The trial plans to enrol 240 participants in the United States and Europe.[4] Study sites are located in London, Manchester, Oxford, Bath and Sheffield in the United Kingdom.[3] The first participant in Europe was recruited at Oxford University Hospitals in January 2026.[4] The study is open to adults aged 18 and over.[3]
The main measure in the FORTIFY trial is the percent change from baseline of the mean Fat Attenuation Index (FAI) score for the three coronary arteries — the right coronary artery (RCA), the left anterior descending artery (LAD) and the left circumflex artery (LCX).[1] The FAI score is a biomarker developed at the University of Oxford that measures the change in structure of the peri-vascular adipose tissue — the fat surrounding the coronary arteries — using a routine heart CT scan. A high FAI score indicates greater inflammation and an increased risk of heart attacks.[4] The trial compares the change in FAI score after 6 months of treatment between participants receiving orticumab and those receiving placebo.[1]
The supplementary sources provided for this page do not contain a specific list of side effects reported for orticumab. The AdisInsight drug profile includes a section on adverse events, but the publicly available excerpt does not detail the individual side effects.[2] As orticumab is still an investigational substance in Phase 2 development, its safety profile is being evaluated in the ongoing FORTIFY trial.[1]
Each condition opens its own overview and trial list
Recruiting trials first
Tell us about your condition – we search every trial in Europe and connect you with the right site.
