Nipocalimab clinical trials
Nipocalimab is named as an intervention in 11 current clinical trials in our USA, Germany, Spain, Italy, Poland, France, Japan, Israel, UK, Netherlands, Brazil, China, Czechia, South Korea, Belgium, Canada, Australia, Switzerland, Mexico, Taiwan, Sweden, Austria, Denmark, Norway, Portugal, Turkey, Ireland and Egypt registers. 9 are recruiting patients now. The most common phase is Phase 3. The lead sponsor is Janssen Research & Development, LLC. The most-studied condition is Myasthenia Gravis.
Where Nipocalimab is approved
All regulators →Of the three regulators tracked here, the first to approve Nipocalimab was the US, on 29 Apr 2025. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for prevention of fetal and neonatal alloimmune thrombocytopenia (, positive)
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 Nipocalimab
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 Nipocalimab works
All drug targets →- IgG receptor FcRn large subunit p51 antagonist AntagonistTarget: FCGRT Fc gamma receptor and transporter✓ In ChEMBL and the Guide to Pharmacology
- Guillain-Barre syndrome, familialPhase 3
- Sjogren syndromePhase 3
- Chronic inflammatory demyelinating polyradiculoneuropathyPhase 3
- Fetal erythroblastosisPhase 3
- Systemic lupus erythematosusPhase 3
- Autoimmune hemolytic anemiaPhase 2/3
- Idiopathic inflammatory myopathyPhase 2
- Lupus nephritisPhase 2
- Rheumatoid arthritisPhase 2
- Autoimmune diseasePhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4594310, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 13876, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Nipocalimab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ImaavyEMA 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.
Trials by status
Trials by phase
Clinical trials of Nipocalimab
11 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Nipocalimab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Nipocalimab on the HPRA medicines list.
- Imaavy 185 mg/mL concentrate for solution for infusionJanssen-Cilag International NV · EU/1/25/1989/001-002
Supply shortages
No entry for Nipocalimab in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- ImaavyEMA · 28 Nov 2025 · Janssen Cilag International NV
Conditions studied with Nipocalimab
8 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Janssen Research & Development, LLC | 11 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Nipocalimab trials
How many clinical trials are testing Nipocalimab?
11 current trials in our USA, Germany, Spain, Italy, Poland, France, Japan, Israel, UK, Netherlands, Brazil, China, Czechia, South Korea, Belgium, Canada, Australia, Switzerland, Mexico, Taiwan, Sweden, Austria, Denmark, Norway, Portugal, Turkey, Ireland and Egypt registers name Nipocalimab (also registered as JNJ-80202135) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Nipocalimab trials recruiting patients?
Yes. 9 of the 11 trials are recruiting: 8 with sites in USA, 6 with sites in Germany, 6 with sites in Spain, 6 with sites in Italy, 6 with sites in Poland, 5 with sites in France, 5 with sites in Japan, 5 with sites in Israel, 4 with sites in UK, 3 with sites in Netherlands, 3 with sites in Brazil, 3 with sites in China, 3 with sites in Czechia, 3 with sites in South Korea, 4 with sites in Belgium, 3 with sites in Canada, 4 with sites in Australia, 3 with sites in Switzerland, 3 with sites in Mexico, 3 with sites in Taiwan, 3 with sites in Sweden, 2 with sites in Austria, 2 with sites in Denmark, 2 with sites in Norway, 2 with sites in Portugal, 1 with sites in Turkey and 1 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Nipocalimab clinical trials?
The lead sponsor is Janssen Research & Development, LLC. The number in brackets is how many trials each organisation leads.
Are there Nipocalimab clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Nipocalimab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Nipocalimab, for example Imaavy 185 mg/mL concentrate for solution for infusion (Janssen-Cilag International NV). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Nipocalimab shortage?
Not in the lists we track: Nipocalimab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Nipocalimab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Nipocalimab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Nipocalimab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.