Where Daratumumab is approved
All regulators →Of the three regulators tracked here, the first to approve Daratumumab was the US, on 16 Nov 2015. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of AL amyloidosis (25 May 2018, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Daratumumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Daratumumab works
All drug targets →- Lymphocyte differentiation antigen CD38 inhibitor InhibitorTarget: CD38 CD38 molecule✓ In ChEMBL and the Guide to Pharmacology
- AL amyloidosisPhase 3
- Acute leukemiaPhase 3
- Autoimmune encephalitisPhase 3
- LeukemiaPhase 3
- Smoldering plasma cell myelomaPhase 3
- T-lymphoblastic lymphomaPhase 2/3
- Neuromyelitis opticaPhase 2/3
- Alzheimer diseasePhase 2
- B-cell chronic lymphocytic leukemiaPhase 2
- Evans syndromePhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1743007, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7395, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Daratumumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 12 technology appraisals of Daratumumab. 11 are current, and 6 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Daratumumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: DarzalexEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Daratumumab
- ATC code
- L01XC24
- ChEMBL
- CHEMBL1743007
- DrugBank
- DB09331
- CAS number
- 945721-28-8
- FDA UNII
- 4Z63YK6E0E
- Wikidata
- Q5222113
- Wikipedia
- Daratumumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Darzalex is used for
Daratumumab (Darzalex) is an antibody therapy for multiple myeloma. It belongs to the CD38 monoclonal antibody class.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 9 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.