DARZALEX (daratumumab)
DARZALEX is indicated for the treatment of Newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant, in combination with lenalidomide and dexamethasone; Newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant, in combination with bortezomib, melphalan, and prednisone; Newly diagnosed multiple myeloma in patients eligible for autologous stem cell transplant, in combination with bortezomib, thalidomide, and dexamethasone; Relapsed or refractory multiple myeloma in patients who have received at least one prior therapy, in combination with lenalidomide and dexamethasone; Multiple myeloma in patients who have received at least one prior therapy, in combination with bortezomib and dexamethasone; Relapsed or refractory multiple myeloma in patients who have received one to three prior lines of therapy, in combination with carfilzomib and dexamethasone; Multiple myeloma in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, in combination with pomalidomide and dexamethasone; Multiple myeloma as monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.
How DARZALEX Works
Daratumumab is a human monoclonal antibody that binds to CD38, a glycoprotein expressed on the surface of multiple myeloma cells. Once bound, it inhibits tumor cell growth by inducing direct apoptosis and triggering immune-mediated cell lysis through complement-dependent cytotoxicity and antibody-dependent cellular phagocytosis. The drug also decreases specific subsets of immune-suppressive cells, including regulatory T cells and B cells, that express the CD38 protein.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-11-16
- PDUFA Date
- 2026-08-17 (83d)
- Patent Cliff
- 2029
- Revenue
- $3.8B (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DARZALEX Approval History
What DARZALEX Treats
8 indicationsDARZALEX is approved for 8 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant, in combination with lenalidomide and dexamethasone
- Newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant, in combination with bortezomib, melphalan, and prednisone
- Newly diagnosed multiple myeloma in patients eligible for autologous stem cell transplant, in combination with bortezomib, thalidomide, and dexamethasone
- Relapsed or refractory multiple myeloma in patients who have received at least one prior therapy, in combination with lenalidomide and dexamethasone
- Multiple myeloma in patients who have received at least one prior therapy, in combination with bortezomib and dexamethasone
- Relapsed or refractory multiple myeloma in patients who have received one to three prior lines of therapy, in combination with carfilzomib and dexamethasone
- Multiple myeloma in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, in combination with pomalidomide and dexamethasone
- Multiple myeloma as monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent
DARZALEX Target & Pathway
ProTarget
A protein highly expressed on multiple myeloma cells. Anti-CD38 antibodies target and kill myeloma cells through multiple mechanisms, becoming a backbone of myeloma treatment across disease stages.
DARZALEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DARZALEX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DARZALEX treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
226 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06615479 | CA088-1007 | Ph 3 | recruiting | A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2) |
| NCT05497804 | MC210811 P50CA186781, 22-002687 | Ph 2 | active not recruiting | Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial |
| NCT07095452 | M25-586 2025-520897-21, 2025-520897-21-00 | Ph 2, Ph 3 | recruiting | A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant |
| NCT06182774 | MY13 | Ph 3 | recruiting | Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma |
| NCT05849610 GEM-TECTAL | GEM-TECTAL | Ph 2 | active not recruiting | Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma |
| NCT04973605 | BGB-11417-105 2023-507751-30-00, 2021-003614-39 | Ph 1, Ph 2 | recruiting | A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma |
| NCT04181827 CARTITUDE-4 results posted | CR108695 68284528MMY3002, 2019-001413-16 | Ph 3 | active not recruiting | A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma |
| NCT05083169 MajesTEC-3 | CR109049 64007957MMY3001, 2020-004742-11 | Ph 3 | active not recruiting | A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT05527340 | GEM-IBERDARAX 2021-002190-25 | Ph 2 | active not recruiting | Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients. |
| NCT07222761 LINKER-MM5 | R5458-ONC-2246 2024-519504-27-00 | Ph 3 | recruiting | A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) |
| NCT03901963 AURIGA results posted | CR108599 54767414MMY3021 | Ph 3 | active not recruiting | A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant |
| NCT04108195 | CR108620 64407564MMY1002, 2019-000330-19 | Ph 1 | active not recruiting | A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma |
| NCT06577025 aMMbition | 54767414MMY2093 54767414MMY2093, 2023-505792-71-00 | Ph 2 | active not recruiting | A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma |
| NCT05438043 | CR109200 54767414MMY3030, 2021-006494-33 | Ph 3 | recruiting | A Study of Daratumumab |
| NCT05552222 MajesTEC-7 | CR109237 64007957MMY3005, 2022-000909-28 | Ph 3 | recruiting | A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma |
| NCT04722146 MajesTEC-2 | CR108927 64007957MMY1004, 2020-004404-33 | Ph 1 | active not recruiting | A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma |
| NCT06768489 | 79635322MMY1002 79635322MMY1002, 2024-515316-44-00 | Ph 1 | recruiting | A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma |
| NCT06413498 iMMagine-3 | KT-US-679-0788 2024-511188-26, jRCT2043240170 | Ph 3 | recruiting | A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma |
| NCT03556332 | 17-493 | Ph 2 | active not recruiting | A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Refractory Myeloma With Salvage Autologous Hematopoietic Cell Transplantation |
| NCT03937635 | EAA173 NCI-2018-02611, EAA173 | Ph 3 | recruiting | Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma |
| NCT03477539 results posted | MC1785 NCI-2018-00332, MC1785 | Ph 2 | completed | Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma |
| NCT05623020 MagnetisMM-6 | C1071006 MAGNETISMM-6, 2024-514139-50-00 | Ph 3 | recruiting | A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant |
| NCT05020236 MAGNETISMM-5 | C1071005 MAGNETISMM-5, 2023-509208-14-00 | Ph 3 | recruiting | A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments |
| NCT06348147 | LCCC2323 | Ph 2 | suspended | Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation |
| NCT02343042 STOMP | KCP-330-017 | Ph 1, Ph 2 | active not recruiting | Selinexor and Backbone Treatments of Multiple Myeloma Patients |
| NCT04933539 | 210024 21-C-0024 | Ph 2 | active not recruiting | Subcutaneous Daratumumab, Once Weekly Carfilzomib, and Dexamethasone (DKd) in Patients With High-Risk Smoldering Multiple Myeloma |
| NCT07391657 DURGA-4 | D8311C00001 AZD0120 | Ph 3 | recruiting | A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4) |
| NCT07555938 CEVOLUTION | CO46096 2025-524028-23-00 | Ph 3 | not yet recruiting | Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma |
| NCT04922723 PRIDE | 2109412076 IND# Pending | Ph 1, Ph 2 | active not recruiting | Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma |
| NCT03622775 results posted | 2016-0681 NCI-2018-01432, 2016-0681 | Ph 2 | terminated | Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant |
| NCT06974786 FASTER | MM 195 | Ph 2 | recruiting | Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma |
| NCT06868654 DREAMM 7 results posted | 207503-CHN | Ph 3 | active not recruiting | China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma |
| NCT06868667 DREAMM 7 results posted | 207503-JPN | Ph 3 | active not recruiting | Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma |
| NCT02316106 results posted | CR106449 54767414SMM2001, 2014-005139-14 | Ph 2 | completed | A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma |
| NCT04246047 DREAMM 7 results posted | 207503 2023-510537-28-00 | Ph 3 | active not recruiting | Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma |
| NCT06679101 DREAMM-10 | 214828 2024-516030-35 | Ph 3 | recruiting | A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM) |
| NCT05392946 | MC200807 21-006604 | Ph 1, Ph 2 | active not recruiting | Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study |
| NCT07513129 | 2025-1869 NCI-2026-02416 | Ph 1 | not yet recruiting | Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma |
| NCT04166565 EMN19 | EMN19 2019-000991-41 | Ph 2 | active not recruiting | Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease |
| NCT06083922 | 22-424 | Ph 2 | recruiting | A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS) |
| NCT03763162 | 2018-0512 NCI-2018-02830, 2018-0512 | Ph 2 | active not recruiting | Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma |
| NCT07107529 | EMN37 2024-520433-76-00 | Ph 2 | recruiting | Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab. |
| NCT04972942 ALLO-T-DART | NYMC-598 | Ph 1 | recruiting | Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma |
| NCT05434689 COMMANDER | UAB-21113 Amgen, Inc, BMS | Ph 1, Ph 2 | active not recruiting | COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide |
| NCT04667663 CPD-DARA | CTRIAL-IE-19-17 2019-004386-40 | Ph 1 | active not recruiting | CPD-DARA in Patients With Relapsed/Refractory Multiple Myeloma. |
| NCT05455320 MonumenTAL-3 | CR109082 64407564MMY3002, 2021-000202-22 | Ph 3 | active not recruiting | A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment |
| NCT03500445 | IRB17-1097 | Ph 2 | active not recruiting | Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma |
| NCT05250973 AQUARIUS | CR109160 54767414AMY2009, 2021-002639-48 | Ph 2 | active not recruiting | A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis |
| NCT04133636 CARTITUDE-2 | CR108581 68284528MMY2003, 2018-004124-10 | Ph 2 | active not recruiting | A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma |
| NCT03652064 results posted | CR108529 54767414MMY3019, 2018-001545-13 | Ph 3 | active not recruiting | A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy |
Showing 50 of 226 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DARZALEX FDA Label Details
Indications & Usage
FDA Label (PDF)DARZALEX is indicated for the treatment of Newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant, in combination with lenalidomide and dexamethasone; Newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant, in combination with bortezomib, melphalan, and prednisone; Newly diagnosed multiple myeloma in patients eligible for autologous stem cell transplant, in combination with bortezomib, thalidomide, and dexamethasone; Relapsed or refractory multiple myeloma in patients who have received at least one prior therapy, in combination with lenalidomide and dexamethasone; Multiple myeloma in patients who have received at least one prior therapy, in combination with bortezomib and dexamethasone; Relapsed or refractory multiple myeloma in patients who have received one to three prior lines of therapy, in combination with carfilzomib and dexamethasone; Multiple myeloma in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, in combination with pomalidomide and dexamethasone; Multiple myeloma as monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.
Pro Intelligence Preview
Deep insights for DARZALEX
Revenue Insights
- • Q4-2025: $3.8B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • Generic/biosimilar risk
Trial Analysis
- • 232 total trials
- • Stage: Growth
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment