Drug Type Monoclonal antibody |
Synonyms Daratumumab (Genetical Recombination), 达拉图单抗, 达雷木单抗 + [7] |
Target |
Action inhibitors |
Mechanism CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (16 Nov 2015), |
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan), Fast Track (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10777 | Daratumumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Smoldering Multiple Myeloma | European Union | 24 Jul 2025 | |
| Smoldering Multiple Myeloma | Iceland | 24 Jul 2025 | |
| Smoldering Multiple Myeloma | Liechtenstein | 24 Jul 2025 | |
| Smoldering Multiple Myeloma | Norway | 24 Jul 2025 | |
| Immunoglobulin Light-Chain Amyloidosis | European Union | 20 May 2016 | |
| Immunoglobulin Light-Chain Amyloidosis | Iceland | 20 May 2016 | |
| Immunoglobulin Light-Chain Amyloidosis | Liechtenstein | 20 May 2016 | |
| Immunoglobulin Light-Chain Amyloidosis | Norway | 20 May 2016 | |
| Refractory Multiple Myeloma | European Union | 20 May 2016 | |
| Refractory Multiple Myeloma | Iceland | 20 May 2016 | |
| Refractory Multiple Myeloma | Liechtenstein | 20 May 2016 | |
| Refractory Multiple Myeloma | Norway | 20 May 2016 | |
| Relapse multiple myeloma | European Union | 20 May 2016 | |
| Relapse multiple myeloma | Iceland | 20 May 2016 | |
| Relapse multiple myeloma | Liechtenstein | 20 May 2016 | |
| Relapse multiple myeloma | Norway | 20 May 2016 | |
| Multiple Myeloma | United States | 16 Nov 2015 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Residual Neoplasm | Phase 3 | United States | 26 Apr 2019 | |
| Residual Neoplasm | Phase 3 | Canada | 26 Apr 2019 | |
| Amyloidosis | Phase 3 | United States | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | United States | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Japan | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Japan | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Australia | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Australia | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Belgium | 10 Oct 2017 | |
| Amyloidosis | Phase 3 | Belgium | 10 Oct 2017 |
Phase 2 | 42 | zshgtkjira = rkmeqzehhj cvuicyaygp (xawwkvoaxu, llzflhmeax - otxvjhmfdz) View more | - | 27 Mar 2026 | |||
Phase 2 | 49 | spfeejvlkr = uuhdpwvedi nvfkgmcpcg (lljjzczfqe, tjztlsjfxj - blzxivppbe) View more | - | 09 Mar 2026 | |||
Phase 2 | 13 | iccppekyhz = iuqtxgirzg istwmqitgb (ouwrewmbze, snwhusnbbg - tmkvwhofap) View more | - | 10 Feb 2026 | |||
Not Applicable | 72 | bgqxpzfrzz(qtqsbbsjwt) = svfdgqltjg jhdkwbwdvb (hfalsebwhs ) View more | Positive | 04 Feb 2026 | |||
bgqxpzfrzz(qtqsbbsjwt) = dwrmworqpw jhdkwbwdvb (hfalsebwhs ) View more | |||||||
Not Applicable | 140 | (CD34+ cells <5×10^6/kg) | empfyvzvwr(xvhtpjnpcg) = nphgwqoecm zkircchghc (mrdptazave ) View more | Positive | 04 Feb 2026 | ||
(CD34+ cells ≥5×10^6/kg) | empfyvzvwr(xvhtpjnpcg) = dauisgjwlx zkircchghc (mrdptazave ) View more | ||||||
Not Applicable | 71 | bfjsucqjwf(hnjqwmgisf) = lgiijjmtch wvrymflmwo (kewlsmsapg ) View more | Positive | 04 Feb 2026 | |||
(2025 IMS/IMWG high-risk criteria) | bfjsucqjwf(hnjqwmgisf) = eefncnqskb wvrymflmwo (kewlsmsapg ) View more | ||||||
Phase 3 | 390 | qmrkuefygp(qhujjwkhmu) = qlbvbiaqmo igigzqttcb (cqgawrqtet, thhaicydvt - dbgarvvyfk) View more | - | 23 Dec 2025 | |||
Phase 2 | Multiple Myeloma First line | 27 | qpbjyedcbh(mayrumalio) = tuatbgbqvh zuyogmwlzq (odhgnmqcaw ) View more | Positive | 16 Dec 2025 | ||
Phase 2 | 24 | (MCD) | kaxfzccpaw(qwqnabuoem) = jgagfksycn phfzqgymot (qvwrtitpiv, 1.1 - 45.7) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 232 | (vWF:Ag <210 U/dL) | rbuutfytpa(ckyhlkowbz) = rvogtimhnv zozmhwurvy (anplkmponp ) View more | Positive | 06 Dec 2025 | ||
(vWF:Ag ≥210 U/dL) | rbuutfytpa(ckyhlkowbz) = uubfalvfei zozmhwurvy (anplkmponp ) View more |






