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FDA Medication Tracker

← All approvals · Women's & hormonal health · 2024

Yorvipath (palopegteriparatide)

The FDA approved Yorvipath (palopegteriparatide) on August 9, 2024 to treat hypoparathyroidism.
Brand name
Yorvipath
Generic name
palopegteriparatide
FDA approval date
August 9, 2024
Approved use (FDA wording)
To treat hypoparathyroidism
Company
Ascendis Pharma Bone
Application
NDA216490
Dosage form / route
SOLUTION · SUBCUTANEOUS
Boxed warning on label
Not listed
Category on this site
Women's & hormonal health

Indications and usage, from the FDA label

YORVIPATH is indicated for the treatment of hypoparathyroidism in adults. YORVIPATH is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults. ( 1 ) Limitations of Use : Not studied for acute post-surgical hypoparathyroidism. ( 1 ) Titration scheme only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment. ( 1 ) Limitations of Use YORVIPATH was not studied for acute post-surgical hypoparathyroidism. YORVIPATH's titration scheme was only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vita…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.