calcimimetic peptide

Etelcalcetide

US: FDA-approvedEU: AuthorisedUK: AuthorisedCA: Not on the registerAU: Status unknownCH: AuthorisedBR: Not on the registerRS: AuthorisedSG: RegisteredTR: Ruhsatli

Answer

Etelcalcetide is authorised or registered in the US, the EU, the UK, Switzerland, Serbia, Singapore and Turkey: 7 of the 10 registers read. Highest trial phase: Phase 3 (1 phase 3 trial, 0 with posted results). It has 24 registered trials, 3 of them running. Brand names on the FDA label register: Parsabiv.

RegulatorTrial register10 regulators' registers, read 2026-09-03 to 2026-10-03 · ClinicalTrials.gov and EU CTIS, read 2026-10-03

Not medical, legal or regulatory advice.

Registered trials24Trial register ClinicalTrials.gov and EU CTIS
Running now3Trial register recruiting, active or enrolling
Results posted16Trial register with results on the register
Stopped early4.2%Trial register all peptides: 10%

24 trials by status

Trial register
Running 3Completed 19Stopped early 1Other or not stated 1

ClinicalTrials.gov and EU CTIS · read 2026-10-03 · 16 trials have posted results

Trials first submitted per year

Trial register

ClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 1 trial carries no first-submitted date (EU CTIS publishes none, or the year is outside this range).

Status by jurisdiction

World map
Authorised or registeredNot on the register, or withdrawnNot read yet, or status unknown
WhereStatusRegisterRead
United StatesFDA-approvedFDA, openfda2026-10-03
European UnionAuthorisedEMA, ema2026-10-03
United KingdomAuthorisedMHRA, uk-mhra2026-10-03
CanadaNot on the registerHealth Canada, ca-dpd2026-09-03
AustraliaStatus unknownTGA, au-artgnot read
SwitzerlandAuthorisedSwissmedic, ch-swissmedic2026-10-03
BrazilNot on the registerANVISA, br-anvisa2026-09-03
SerbiaAuthorisedALIMS, rs-alims2026-09-03
SingaporeRegisteredHSA, sg-hsa2026-09-03
TurkeyRuhsatliTITCK, tr-titck2026-09-03

An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.

Side effects

Trial register
4 placebo-controlled trials · 1,031 people on Etelcalcetide · grey is placebo
Blood calcium decreased46.6% 30.3%
Diarrhoea10.6% 9.3%
Muscle spasms10% 7.8%
Nausea9.1% 8.1%
Vomiting8.9% 7.3%
ClinicalTrials.gov posted results · read 2026-10-03All side effects

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REGISTERED TRIALS

Newest 10 of 24 trials

All 24 trials
NCT03969329
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
currently recruiting participants · register updated 2026-08-21
NCT06690242
MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease
completed · register updated 2026-07-22
2023-506471-10-00
Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Chil
no status recorded · register updated 2026-06-10
NCT03633708
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
currently recruiting participants · register updated 2026-02-27
NCT06352957
Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study
not yet recruiting participants · register updated 2024-04-08
NCT03960437
The Effect of Etelcalcetide on CKD-MBD
completed · register updated 2023-09-21
NCT03795558
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dial
completed · register updated 2022-03-23
NCT03299244
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
completed · register updated 2021-04-30
NCT03182699
Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients
completed · register updated 2020-06-09
NCT03527511
Effect of Active Vitamin D and Etelcalcetide on Human Osteoclasts in Patients With Chronic Kidney Disease
completed · register updated 2020-03-31

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