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Daratumumab Injection
Daratumumab Injection is a CD38-targeting monoclonal antibody Small molecule drug developed by Charite University, Berlin, Germany. It is currently in Phase 3 development for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain myeloma. Also known as: DARZALEX (trade name), Darzalex.
Daratumumab is a monoclonal antibody that binds to CD38 on the surface of plasma cells and multiple myeloma cells, triggering their destruction through multiple immune mechanisms.
Daratumumab Injection is an antibody that targets the lymphocyte differentiation antigen CD38, and it is used to treat conditions such as relapsed or refractory multiple myeloma, multiple myeloma, non-Hodgkin lymphoma, B-cell lymphoma, and amyloidosis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Daratumumab Injection |
|---|---|
| Also known as | DARZALEX (trade name), Darzalex |
| Sponsor | Charite University, Berlin, Germany |
| Drug class | CD38-targeting monoclonal antibody |
| Target | CD38 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Daratumumab targets CD38, a surface antigen highly expressed on malignant plasma cells in multiple myeloma. Upon binding, it induces cell death through antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). This multi-modal mechanism makes it effective in both newly diagnosed and relapsed/refractory multiple myeloma.
Approved indications
- Multiple myeloma (newly diagnosed and relapsed/refractory)
- Light chain myeloma
Common side effects
- Infusion-related reactions
- Fatigue
- Nausea
- Anemia
- Thrombocytopenia
- Neutropenia
- Upper respiratory tract infection
Key clinical trials
- A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments (PHASE3)
- A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma (PHASE3)
- 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 (PHASE2, PHASE3)
- A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma (PHASE1, PHASE2)
- Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing (PHASE2)
- 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 (PHASE3)
- A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (PHASE3)
- 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 (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Daratumumab Injection CI brief — competitive landscape report
- Daratumumab Injection updates RSS · CI watch RSS
- Charite University, Berlin, Germany portfolio CI
Frequently asked questions about Daratumumab Injection
What is Daratumumab Injection?
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Related
- Drug class: All CD38-targeting monoclonal antibody drugs
- Target: All drugs targeting CD38
- Manufacturer: Charite University, Berlin, Germany — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma (newly diagnosed and relapsed/refractory)
- Indication: Drugs for Light chain myeloma
- Also known as: DARZALEX (trade name), Darzalex
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing