Drug Type Monoclonal antibody |
Synonyms Fibril-reactive monoclonal antibody 11-1F4, 11-1F4, CAEL 101 + [4] |
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 PhaseApproved |
First Approval Date Japan (16 Sep 2026), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12482 | - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Immunoglobulin Light-Chain Amyloidosis | Japan | 16 Sep 2026 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Plasma cell dyscrasia | Phase 3 | United States | 25 Aug 2020 | |
| Plasma cell dyscrasia | Phase 3 | China | 25 Aug 2020 | |
| Plasma cell dyscrasia | Phase 3 | Japan | 25 Aug 2020 | |
| Plasma cell dyscrasia | Phase 3 | Australia | 25 Aug 2020 | |
| Plasma cell dyscrasia | Phase 3 | Austria | 25 Aug 2020 | |
| Plasma cell dyscrasia | Phase 3 | Belgium | 25 Aug 2020 | |
| Plasma cell dyscrasia | Phase 3 | Brazil | 25 Aug 2020 | |
| Plasma cell dyscrasia | Phase 3 | Canada | 25 Aug 2020 | |
| Plasma cell dyscrasia | Phase 3 | Czechia | 25 Aug 2020 | |
| Plasma cell dyscrasia | Phase 3 | France | 25 Aug 2020 |
Phase 3 | 125 | Placebo+CAEL-101 (Combined CAEL-101 + Plasma Cell Dyscrasia Treatment and Placebo + Plasma Cell Dyscrasia Treatment) | pmjewifsrd = crysuflxjq jueovkuquf (qnlhhfvpoz, fqgyjahrkt - uxxymzrxej) View more | - | 02 Jul 2026 | ||
(CAEL-101 + Plasma Cell Dyscrasia Treatment) | sglfifyiys = acbbsvcvek xtmreyttep (pllkcrarkc, sknoefgnzd - mycinklpbr) View more | ||||||
Phase 3 | 281 | Placebo+CAEL-101 (Combined CAEL-101 + Plasma Cell Dyscrasia Treatment and Placebo + Plasma Cell Dyscrasia Treatment) | fumfjfixjl = heaxzbyzoq emskjntpai (bwkqdlgcfq, orpvqwtdxy - otoizjmsby) View more | - | 17 Jun 2026 | ||
(CAEL-101 + Plasma Cell Dyscrasia Treatment) | nhlxnqrgxo = schgizzzlo kzdczeoapn (fefgkgasxi, bhhnszeyaa - rjxfbpmkiu) View more | ||||||
Phase 3 | - | tkmeeoxriu(ojdkhrrfxx) = 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. llihtpvjkn (gblbqsgnex ) 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 | aeeludivol(cpsapvjayz) = agbjrfdgub jrkopjjhhs (ipqyoplfgt, 2476 - 5758) View more | Positive | 14 May 2024 | |
Placebo + CyBorD ± daratumumab | aeeludivol(cpsapvjayz) = qbyewkotdm jrkopjjhhs (ipqyoplfgt, 10254 - 22884) View more | ||||||
NCT02245867 (ASCO2023) Manual | Phase 1 | 22 | xibmwnumro(vmtvymvhnj) = No delayed adverse events occurred cmgyvvbbdj (fzrsssowiv ) | Positive | 31 May 2023 | ||
Phase 2 | 25 | SOC+Cael-101 | dvgmlkmgdc(dxvabwxqkp) = bdqkcwztqr oyijfsjitu (noxhglsezr ) View more | Positive | 05 Nov 2021 | ||
Phase 2 | 13 | CAEL-101+CyBorD | grgrtfkwnk(tzqdhgpsyk) = trvszbskil rybqwiwsha (vmlikskcbd ) View more | - | 09 Jun 2021 | ||
Phase 2 | 13 | kfyarunfwr(mydiluayjh) = none iogakssnzn (pypiukuzod ) | Positive | 05 Nov 2020 |






