Drugs / Anselamimab
last change Jul 2026 re-read 9 days ago

Anselamimab

also known as CAEL-101 · 11-1F4 · Mu 11-F4

Protein / enzyme biologic

Developed for
AL amyloidosis
Investigated by
Alexion Pharmaceuticals, Inc. · Stanford University · University of Tennessee

Trials 6

200920102011201220132014201520162017201820192020202120222023202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07615270 Jul 2026 → Jul 2028 expected AL amyloidosis Stanford University Not yet recruiting No outcome recorded
Phase 12 trials
Phase 1 NCT02245867 Oct 2014 → Jul 2017 AL amyloidosis Alexion Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT01815086 Dec 2008 → Jul 2013 AL amyloidosis University of Tennessee Completed No outcome recorded
Phase 21 trial
Phase 2 NCT04304144 Mar 2020 → Nov 2023 AL amyloidosis Alexion Pharmaceuticals, Inc. Completed No outcome recorded
Phase 32 trials · 2 missed
Phase 3 NCT04512235 Nov 2020 → Apr 2025 overdue AL amyloidosis Alexion Pharmaceuticals, Inc. Active not recruiting Missed primary
Phase 3 NCT04504825 Aug 2020 → May 2025 overdue AL amyloidosis Alexion Pharmaceuticals, Inc. Active not recruiting Missed primary

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2026-05-29 AstraZeneca Results CARES Phase III clinical programme did not meet primary endpoint in overall light chain amyloidosis population, however, demonstrated anselamimab as potential first anti-fibril therapy in kappa light chain amyloidosis astrazeneca.com ↗
Anselamimab demonstrated 62% improvement in survival and 71% reduction in cardiovascular hospitalisations in prespecified kappa light-chain amyloidosis subgroup
2025-07-16 AstraZeneca Results Update on CARES Phase III clinical programme of anselamimab in light chain amyloidosis astrazeneca.com ↗
Anselamimab showed highly clinically meaningful improvement in time to ACM and frequency of CVH in a prespecified subgroup of patients, compared to placebo.
2023-11-29 AstraZeneca Results AstraZeneca advances scientific leadership in haematology at ASH 2023 astrazeneca.com ↗
24-month results of a Phase II trial will demonstrate the safety and tolerability of CAEL-101 in combination with cyclophosphamide-bortezomib-dexamethasone with or without daratumumab for the treatment of AL amyloidosis.

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as Anselamimab ClinicalTrials.gov intervention name — accepted as the source's own label NCT07615270 ↗
Known as 11-1F4 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02245867 ↗
1

NCT01815086 ↗

Known as CAEL-101 “A Pilot Study of CAEL-101/Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement” NCT07615270 ↗
3

NCT04504825 ↗

NCT04304144 ↗

NCT04512235 ↗

Known as Mu 11-F4 “Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody (mAb) Murine (Mu) 11-F4” NCT01815086 ↗
Modality Monoclonal antibody “radiolabeled amyloid-reactive monoclonal antibody (mAb)” NCT01815086 ↗
Route Intravenous “intravenous infusion” NCT01815086 ↗