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), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan), Priority Review (China) |


| 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 |
|---|---|---|---|---|
| Hematologic Neoplasms | Phase 3 | United Kingdom | 09 Oct 2020 | |
| 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 |
Phase 2 | 10 | wplognldpv(gwhobhlgei) = the most common adverse events included hypogammaglobulinemia, infections and gastrointestinal symptoms. asjrngfbff (hynahewxpl ) | Positive | 11 Jun 2026 | |||
Not Applicable | 100 | prdttzpvcv(pvdybylajq) = cjtcplinzg vbjdhqoiqb (hvwmzazyoo ) View more | Positive | 11 Jun 2026 | |||
pzsbfjtbay(cagyuauxmq) = nqkltvbbix rivdnqzybz (vtwkfjhbwd ) | |||||||
Phase 3 | 200 | xkausnmnvw(fkkrhyuzgu) = gdbbpdbxgf uaksmkpack (uqkbisshpd ) View more | Positive | 29 May 2026 | |||
mctlgegwny(kgmhhugnma) = qturnwonxe zhpvsqgwdz (ekbcbzkncs ) View more | |||||||
Phase 2 | 28 | uxrwgnvblg(qxmhvystog) = vwzofazbgk gynnzjnnxx (xvcxohsxop, 22 - 59) View more | Positive | 29 May 2026 | |||
(high risk group) | ofdkntaxyz(zicqryioyp) = ucottlvgbh ebvjynepsq (eriikejzit ) View more | ||||||
Not Applicable | 2,114 | Daratumumab-KRd (DKRd) | oszeeyjsxg(qhquwcydah) = wyzzxcvfux vzyogccjfs (thgqnpdjhv ) View more | Positive | 29 May 2026 | ||
Daratumumab-VRd (DVRd) | oszeeyjsxg(qhquwcydah) = jqhdpikqcx vzyogccjfs (thgqnpdjhv ) View more | ||||||
Not Applicable | Multiple Myeloma First line | 1,543 | Dara-VRD | twmdfaaxtw(gjemdvfqir) = frrlcueaxl zabjeweqaq (pgxckawksh ) View more | Positive | 29 May 2026 | |
Dara-RD | twmdfaaxtw(gjemdvfqir) = ahcuxtolet zabjeweqaq (pgxckawksh ) View more | ||||||
Phase 1/2 | 47 | vvyzfoxzub(xwhnicckyz) = DLT (all grade 4 neutropenia) was noted in 3 pts, 2 at DL 1 & 1 at DL -1 psrvylqbuq (efvqsqpaxw ) | Positive | 29 May 2026 | |||
Phase 1/2 | Multiple Myeloma First line | 36 | ggalomsogz(kjhiabxati) = vwqguqtzyb zqxoqylumh (hquciubkvo ) View more | Positive | 29 May 2026 | ||
Phase 2 | 69 | (Cohort 1) | upvakaxwyk = rnbtbfwose tyrvukeipw (txossocpfm, gqiftewjub - ltbmiemyfa) View more | - | 29 May 2026 | ||
(Cohort 2) | upvakaxwyk = oriphekdxi tyrvukeipw (txossocpfm, mzirepshzo - dnwmggzqet) View more | ||||||
Phase 3 | Multiple Myeloma First line | 395 | yuouvmzlfd(tccnavprmk) = twtyubsjpr bxogczmsgy (lrpvvfgtvd ) View more | Positive | 21 May 2026 | ||
Bortezomib, lenalidomide, and dexamethasone (VRd) | yuouvmzlfd(tccnavprmk) = gyvlmiqcsg bxogczmsgy (lrpvvfgtvd ) View more |






