Etelcalcetide clinical trials
Etelcalcetide is named as an intervention in 2 current clinical trials in our UK, Germany, France, Spain, Italy, Belgium, Poland, Czechia, Portugal, USA, India, Turkey, South Korea, Taiwan and Singapore registers. 2 are recruiting patients now. All registered phases are Phase 3. The lead sponsor is Amgen. The most-studied condition is Secondary Hyperparathyroidism.
Where Etelcalcetide is approved
All regulators →Of the three regulators tracked here, the first to approve Etelcalcetide was the EU, on 11 Nov 2016. It is approved in 2 of the 3 regulators tracked here.
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.
Etelcalcetide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Etelcalcetide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 8 listed patents; the last listed expires 27 Jun 2034 (US 11959486).
- Latest patent on the drug substance itself: 7 Feb 2031 (US 8999932).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Etelcalcetide
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 Etelcalcetide works
All drug targets →- Calcium sensing receptor agonist AgonistTarget: CASR calcium sensing receptor✓ In ChEMBL and the Guide to Pharmacology
- Chronic kidney diseasePhase 3
- Myelodysplastic syndromePhase 3
- HyperparathyroidismPhase 2
- Stage 5 chronic kidney diseasePhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3545184, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8375, 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 Etelcalcetide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Etelcalcetide. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Etelcalcetide for treating secondary hyperparathyroidism NICE TA448 | Optimised | 28 Jun 2017 | Current |
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 Etelcalcetide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ParsabivEMA 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 Etelcalcetide
- ATC code
- H05BX04
- ChEMBL
- CHEMBL3545184
- DrugBank
- DB12865
- PubChem CID
- 71511839
- CAS number
- 1262780-97-1
- FDA UNII
- 60ME133FJB
- Wikidata
- Q21098973
- Wikipedia
- Etelcalcetide
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.
Trials by status
Trials by phase
Clinical trials of Etelcalcetide
2 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
NCT03633708 · Secondary Hyperparathyroidism, Chronic Kidney Disease
|
Phase 3 | Recruiting | Amgen | USA, India, Turkey, South Korea, Taiwan, Singapore |
|
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
NCT03969329 · Secondary Hyperparathyroidism
|
Phase 3 | Recruiting | Amgen | UK, Germany, France, Spain, Italy, Belgium, Poland, Czechia, Portugal |
Registers 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.
Etelcalcetide 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)
3 single-substance products containing Etelcalcetide on the HPRA medicines list.
- Parsabiv 10 mg solution for injectionAmgen Europe B.V., · EU/1/16/1142/009-012
- Parsabiv 2.5 mg solution for injectionAmgen Europe B.V., · EU/1/16/1142/001-004
- Parsabiv 5 mg solution for injectionAmgen Europe B.V., · EU/1/16/1142/005-008
Supply shortages
No entry for Etelcalcetide in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Etelcalcetide
2 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Amgen | 2 |
By country register
A trial with sites in more than one country appears in each of those registers.
Questions about Etelcalcetide trials
How many clinical trials are testing Etelcalcetide?
2 current trials in our UK, Germany, France, Spain, Italy, Belgium, Poland, Czechia, Portugal, USA, India, Turkey, South Korea, Taiwan and Singapore registers name Etelcalcetide as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Etelcalcetide trials recruiting patients?
Yes. 2 of the 2 trials are recruiting: 1 with sites in UK, 1 with sites in Germany, 1 with sites in France, 1 with sites in Spain, 1 with sites in Italy, 1 with sites in Belgium, 1 with sites in Poland, 1 with sites in Czechia, 1 with sites in Portugal, 1 with sites in USA, 1 with sites in India, 1 with sites in Turkey, 1 with sites in South Korea, 1 with sites in Taiwan and 1 with sites in Singapore. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Etelcalcetide clinical trials?
The lead sponsor is Amgen. The number in brackets is how many trials each organisation leads.
Is Etelcalcetide licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Etelcalcetide, for example Parsabiv 10 mg solution for injection (Amgen Europe B.V.,). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Etelcalcetide shortage?
Not in the lists we track: Etelcalcetide 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 Etelcalcetide 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 Etelcalcetide 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 Etelcalcetide (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.