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Drug

Palopegteriparatide

Approved medicine
ResearchActive indication expansion

Also known as Mpeg 40000-teriparatide, Teriparatide, Yorvipath, Human parathyroid hormone (PTH) synthetic peptide fragment (1-34), conjugated at the N-terminal amino group via a cleavable linker to O-methylpolyethylene glycol (2 x 20 kDa mPEG); 2-methylalanyl-(1-34)-peptide of parathyroid hormone (Homo sapiens parath.

RxNorm2693635UNIIG2N64C3385
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Palopegteriparatide
Aliases & brands
Mpeg 40000-teriparatideTeriparatideYorvipathHuman parathyroid hormone (PTH) synthetic peptide fragment (1-34), conjugated at the N-terminal amino group via a cleavable linker to O-methylpolyethylene glycol (2 x 20 kDa mPEG); 2-methylalanyl-(1-34)-peptide of parathyroid hormone (Homo sapiens parath
RxNorm CUI
2693635
UNII
G2N64C3385
Regulatory jurisdictions
emafda

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2023-11-17 → 2025-10-16)
Earliest approval
2023-11-17
Latest approval
2025-10-16
Authorities
FDA · EMA
Total events
4
fdaU.S. Food and Drug Administration· 3 events
2026-08-03Label change
Label change: PALOPEGTERIPARATIDE (NDA216490)
Evidence ↗
2025-10-16Supplemental approvalMulti-authority
Supplemental approval: PALOPEGTERIPARATIDE (NDA216490)
Evidence ↗
2024-08-09ApprovalMulti-authority
Approval: PALOPEGTERIPARATIDE (NDA216490)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2023-11-17ApprovalMulti-authority
Approval: Yorvipath (EMA)

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

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Regulatory event sources are credited in the Regulatory Timeline above.