Is Palopegteriparatide approved by the US FDA?

Drugs@FDA lists 1 application product line for Palopegteriparatide, including YORVIPATH (Prescription).

Is Palopegteriparatide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Palopegteriparatide: Yorvipath.

Are there safety signals or safety updates for Palopegteriparatide?

US FDA: 1 entry (latest 2026-08-03).

Active substance

Palopegteriparatide

US FDA 1
EMA 1
Health Canada 2
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML); EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML); EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	solution · subcutaneous	ASCENDIS PHARMA BONE	Prescription	9 Aug 2024

EMA European Union — centrally authorised medicines

Yorvipath Ascendis Pharma Bone Diseases A/S · Authorised · authorised 17 Nov 2023 · ATC H05AA

Therapeutic indication (EMA)

Yorvipath is a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
YORVIPATH	02565161	294 MCG / 0.98 ML	SOLUTION · SUBCUTANEOUS	PENDOPHARM DIVISION OF PHARMASCIENCE INC
YORVIPATH	02565188	420 MCG / 1.4 ML	SOLUTION · SUBCUTANEOUS	PENDOPHARM DIVISION OF PHARMASCIENCE INC

Safety signals and safety-related labeling changes

US FDA 3 Aug 2026 YORVIPATH — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for palopegteriparatide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.