Drug Type Monoclonal antibody |
Synonyms Fibril-reactive monoclonal antibody 11-1F4, 11-1F4, CAEL 101 + [2] |
Target |
Action inhibitors |
Mechanism APP inhibitors(Beta amyloid A4 protein inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12482 | - | - | - |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Immunoglobulin Light-Chain Amyloidosis | Phase 3 | United States | 25 Aug 2020 | |
| Immunoglobulin Light-Chain Amyloidosis | Phase 3 | United States | 25 Aug 2020 | |
| Immunoglobulin Light-Chain Amyloidosis | Phase 3 | China | 25 Aug 2020 | |
| Immunoglobulin Light-Chain Amyloidosis | Phase 3 | Japan | 25 Aug 2020 | |
| Immunoglobulin Light-Chain Amyloidosis | Phase 3 | Japan | 25 Aug 2020 | |
| Immunoglobulin Light-Chain Amyloidosis | Phase 3 | Australia | 25 Aug 2020 | |
| Immunoglobulin Light-Chain Amyloidosis | Phase 3 | Australia | 25 Aug 2020 | |
| Immunoglobulin Light-Chain Amyloidosis | Phase 3 | Austria | 25 Aug 2020 | |
| Immunoglobulin Light-Chain Amyloidosis | Phase 3 | Austria | 25 Aug 2020 | |
| Immunoglobulin Light-Chain Amyloidosis | Phase 3 | Belgium | 25 Aug 2020 |
Phase 3 | 125 | Placebo+CAEL-101 (Combined CAEL-101 + Plasma Cell Dyscrasia Treatment and Placebo + Plasma Cell Dyscrasia Treatment) | sjuwfrrwgp = cyiliybhel zjsdccisrd (lchdnompuj, dxqzekzjme - xxpyxgjbjw) View more | - | 02 Jul 2026 | ||
(CAEL-101 + Plasma Cell Dyscrasia Treatment) | uekdtphmmp = ubpbicqvok ojoasjbrtq (hedlslkxsn, chnabnztks - wmzhrkzisn) View more | ||||||
Phase 3 | 281 | Placebo+CAEL-101 (Combined CAEL-101 + Plasma Cell Dyscrasia Treatment and Placebo + Plasma Cell Dyscrasia Treatment) | jzamwczzij = gtfocsgrva wgtihqlzlc (aeyckyiery, ipgahigqzz - mnoiaulbxx) View more | - | 17 Jun 2026 | ||
(CAEL-101 + Plasma Cell Dyscrasia Treatment) | xcroxgtvkr = neqkeuruaa gfklegrvni (qhllieqlsp, fixekavqqp - gfnfawysls) View more | ||||||
Phase 3 | - | sncktoufae(qpclygytgb) = did not achieve statistical significance for the primary endpoint compared to placebo. Anselamimab showed highly clinically meaningful improvement in time to ACM and frequency of CVH in a prespecified subgroup of patients, compared to placebo. rqdvuhyngb (lewhrnsxiw ) Not Met | Negative | 16 Jul 2025 | |||
Placebo | |||||||
Phase 3 | Immunoglobulin Light-Chain Amyloidosis First line N-terminal pro b-type natriuretic peptide (NT-proBNP) | involved/uninvolved free light chain difference (dFLC) | - | Anselamimab + CyBorD ± daratumumab | njqezkysef(peiydzbvcx) = cwhzvrzshu mbwfipwsdm (zdmgsmuwyk, 2476 - 5758) View more | Positive | 14 May 2024 | |
Placebo + CyBorD ± daratumumab | njqezkysef(peiydzbvcx) = diinoffvhd mbwfipwsdm (zdmgsmuwyk, 10254 - 22884) View more | ||||||
NCT02245867 (ASCO2023) Manual | Phase 1 | 22 | slrqqtowko(gwduvgddua) = No delayed adverse events occurred gkvwncryhu (txzkzcwfiq ) | Positive | 31 May 2023 | ||
Phase 2 | 25 | SOC+Cael-101 | uhatrwcwpy(tsxjvxkcqd) = fptjriyxys lofupjnvck (xphmutlamp ) View more | Positive | 05 Nov 2021 | ||
Phase 2 | 13 | CAEL-101+CyBorD | ehhpudodmt(csehbtpght) = upjexwmxyt swezivxcyh (nmbhnymhsp ) View more | - | 09 Jun 2021 | ||
Phase 2 | 13 | yojuavqawk(ldvzfodsia) = none kisrjdzlph (eftycavrqb ) | Positive | 05 Nov 2020 |






