Etelcalcetide
As of the edition of 20 October 2026, Etelcalcetide is a protein: marketed, first approved in 2016 (EU); acts on CASR; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Protein
- Brand name
- Parsabiv
- First approved
- 11 November 2016 (EU)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- Amgen; 4 holders in all
- Registered trials
- 19, 1 stopped early
- Disease areas
- Hormones; Pregnancy and women's health; Urinary and reproductive; Nutrition and metabolism; Bones, joints and muscles; Cancer
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Amgen.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product12 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 12 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Etelcalcetide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CASR | Extracellular calcium-sensing receptor | P41180 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 5 | 4 | 0 | 1 |
| Phase 3 | 9 | 7 | 2 | 0 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant and Lead sponsor of trials | 2010 to now |
| Ono Pharmaceutical | Applicant | 2016 to now |