Yorvipath (palopegteriparatide)
An approved treatment for Hypoparathyroidism.
The same compound appears under different names depending on the context. Here is how to identify Palopegteriparatide wherever you encounter it, plus the key facts at a glance.
- Generic name
- Palopegteriparatide
- Brand name
- Yorvipath
- Development code
- TransCon PTH
- Drug class
- Parathyroid hormone analog (PTH 1-34 prodrug)
- Manufacturer
- Ascendis Pharma
- How it's taken
- Yorvipath is injected under the skin of the abdomen or front of the thigh once a day from a prefilled pen, rotating the site daily.
A once-daily injection under the skin, from a prefilled pen, that replaces the missing parathyroid hormone in adults with hypoparathyroidism. The FDA approved it on August 9, 2024. In its main trial, 69% of patients on Yorvipath kept normal blood calcium at 26 weeks without active vitamin D or high-dose calcium pills, against 5% on placebo.
Where Palopegteriparatide fits
Yorvipath replaces the missing hormone rather than only making up for low calcium, and in PaTHway most patients could stop active vitamin D and high-dose calcium. The trial compared it with placebo on top of conventional therapy, not with another PTH medicine.
How Palopegteriparatide works
Parathyroid hormone (PTH) keeps blood calcium steady by releasing calcium from bone, helping the kidneys hold on to calcium and get rid of phosphate, and activating vitamin D so the gut absorbs more calcium. In hypoparathyroidism the body makes too little PTH, so calcium runs low and phosphate runs high. Palopegteriparatide is teriparatide, the active first 34 building blocks of human PTH, attached to an inactive carrier by a linker that breaks down gradually in the body. After each daily injection it releases PTH(1-34) continuously, and the released hormone works through the same receptor (PTH1R) in bone and kidney as the body's own PTH[1][4].
Mechanism: Once-daily prodrug of parathyroid hormone (PTH 1-34, teriparatide) attached to an inactive carrier by a TransCon linker that releases the active hormone steadily over 24 hours, replacing the missing hormone
Side effects and safety
- Allergic reactions. Anaphylaxis, angioedema and hives have been reported with PTH medicines, including Yorvipath (warning added August 2026). Stop and get help for signs of an allergic reaction; a severe reaction means stopping for good.
- Serious high calcium (hypercalcemia). Can require hospital care; risk is highest when starting or raising the dose. Calcium is checked 7 to 10 days after each dose change and at least every 4 to 6 weeks on a steady dose.
- Serious low calcium (hypocalcemia). Risk is highest if Yorvipath is stopped suddenly, but it can happen at any time. Do not stop without a plan from your doctor.
- Unintended calcium changes from 2 injections. Use only 1 injection for each daily dose, because splitting a dose into 2 injections makes the delivered amount less predictable.
- Possible osteosarcoma risk. Bone cancer occurred in rats given PTH-type drugs. Not recommended for people at higher risk, such as those with open growth plates, Paget's disease, unexplained high alkaline phosphatase, bone cancer or bone metastases, or past radiation to the skeleton.
- Low blood pressure on standing. Dizziness, fast heartbeat or fainting can occur; take the first doses sitting or lying down.
- Digoxin toxicity. High calcium can make digoxin toxic; calcium and digoxin levels are checked more often when both are used.
- Vitamin D (25-hydroxyvitamin D) in the normal range and albumin-corrected calcium of at least 7.8 mg/dL within 2 weeks before the first dose
- Blood calcium 7 to 10 days after starting and after any change in Yorvipath, active vitamin D or calcium doses
- Blood calcium at least every 4 to 6 weeks once on a steady dose
- Daily watch for symptoms of high or low calcium
Yorvipath has no boxed warning. It must not be used by people who have had a severe allergic reaction to palopegteriparatide or its ingredients, and since August 2026 the label warns that anaphylaxis, angioedema (swelling under the skin) and hives have been reported with PTH medicines, including Yorvipath. In the 26-week PaTHway trial, the most common side effects on Yorvipath against placebo were injection site reactions (39% against 5%), vasodilatory symptoms such as dizziness, a drop in blood pressure on standing, palpitations or fainting (28% against 0%), headache (21% against 10%), diarrhea (10% against 5%), back pain (8% against 0%), high calcium (hypercalcemia, 8% against 0%) and throat pain (7% against 0%). Blood calcium went above the normal range at least once in 54% of patients on Yorvipath against 9.5% on placebo, and symptomatic high calcium happened in 8%, all within the first 3 months. The label also warns about serious high and low calcium, a possible risk of osteosarcoma (a bone cancer) seen in rats given PTH-type drugs, low blood pressure on standing, and digoxin toxicity if calcium runs high[1][3].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Palopegteriparatide
Yorvipath is injected under the skin of the abdomen or front of the thigh once a day from a prefilled pen, rotating the site daily. The usual starting dose is 18 mcg, adjusted in 3 mcg steps, no more often than every 7 days going up or every 3 days going down, to a dose between 6 and 30 mcg that keeps blood calcium normal without active vitamin D or therapeutic calcium doses. On the day Yorvipath starts, active vitamin D and calcium supplements are cut back following a table in the label, and calcium to meet dietary needs may continue. Only 1 injection should be used for each daily dose. The first doses should be given sitting or lying down. A dose less than 12 hours late is taken right away; a dose more than 12 hours late is skipped. Each pen holds 14 days of doses and is kept in the refrigerator until first use, then at room temperature below 86°F for up to 14 days[1].
Availability and cost
Only available as the brand-name product.
Help paying for Yorvipath
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Yorvipath Co-Pay Program: eligible patients with commercial health insurance may pay as little as $5 per month. Not available to people in federal or state healthcare programs such as Medicaid, Medicare, Medigap, VA, DOD or TRICARE, or to cash-paying patients. Terms and conditions apply.
For: private insurance · source - Free medicine program
Ascendis Patient Assistance Program: patients who do not have insurance or are underinsured may qualify for Yorvipath at $0. Full eligibility criteria are in the program terms.
For: no insurance, underinsured · source - Insurance and case manager help
A·S·A·P assigns a Nurse Advocate who helps with benefits checks, the insurance approval process, coverage changes and reauthorizations, and financial help options. Yorvipath ships from Orsini Specialty Pharmacy or PANTHERx Rare Pharmacy. Enrollment starts when the doctor submits an Enrollment Form and signed Patient Consent Form. Call Monday to Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: The Co-Pay Program terms PDF linked from yorvipath.com could not be opened (the site returned a bot check on later requests), so no annual maximum is listed. Offer details come from the support page text.
- From a charity · The Assistance FundHypoparathyroidism fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.”
Access and eligibility
Approved for hypoparathyroidism in adults. It was not studied for acute hypoparathyroidism right after surgery, and its dosing scheme was tested only in adults who first reached an albumin-corrected calcium of at least 7.8 mg/dL on calcium and active vitamin D. Not approved for children, and not recommended for people at higher risk of osteosarcoma. PaTHway enrolled adults aged 18 and older, most of whom had hypoparathyroidism after neck surgery.
Source: Ascendis Signature Access Program (A·S·A·P)
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
PaTHway (NCT04701203) randomized 82 adults with hypoparathyroidism, 85% of them after neck surgery, to Yorvipath (61) or placebo (21) for 26 weeks, on top of calcium and active vitamin D that were then adjusted. The main goal combined normal blood calcium with no active vitamin D, no more than 600 mg a day of calcium, and no dose increase in the final weeks. It was met by 69% (42 of 61) on Yorvipath against 5% (1 of 21) on placebo. At week 26, 95% on Yorvipath were free of active vitamin D and 87% of therapeutic calcium doses, against 24% and 5% on placebo[1][5][7]. In the open-label extension, 39% of the original Yorvipath group still met the strict main goal at weeks 52 and 78, while 64% at week 52 and 66% at week 78 kept normal calcium without active vitamin D or therapeutic calcium when dose increases were allowed[1][6].
Development history
Ascendis Pharma developed palopegteriparatide as TransCon PTH, using its TransCon technology, which attaches a drug to a carrier through a linker that releases it over time[4][1]. Ascendis submitted the application on August 31, 2022, and the FDA issued a complete response letter on April 28, 2023. After a resubmission in November 2023 and major amendments in May 2024 that extended the review by 3 months, the FDA approved Yorvipath for hypoparathyroidism in adults on August 9, 2024[2]. Ascendis announced the approval on August 12, 2024[4]. On August 3, 2026, the FDA approved a label update adding a warning about allergic reactions, which it required for parathyroid hormone products[3].
Explore Hypoparathyroidism trials
Common questions about Palopegteriparatide
▸What is Palopegteriparatide (Yorvipath)?
A once-daily injection under the skin, from a prefilled pen, that replaces the missing parathyroid hormone in adults with hypoparathyroidism. The FDA approved it on August 9, 2024. In its main trial, 69% of patients on Yorvipath kept normal blood calcium at 26 weeks without active vitamin D or high-dose calcium pills, against 5% on placebo.
▸How does Palopegteriparatide work?
Parathyroid hormone (PTH) keeps blood calcium steady by releasing calcium from bone, helping the kidneys hold on to calcium and get rid of phosphate, and activating vitamin D so the gut absorbs more calcium. In hypoparathyroidism the body makes too little PTH, so calcium runs low and phosphate runs high. Palopegteriparatide is teriparatide, the active first 34 building blocks of human PTH, attached to an inactive carrier by a linker that breaks down gradually in the body. After each daily injection it releases PTH(1-34) continuously, and the released hormone works through the same receptor (PTH1R) in bone and kidney as the body's own PTH[1][4].
▸What are the side effects of Palopegteriparatide?
Yorvipath has no boxed warning. It must not be used by people who have had a severe allergic reaction to palopegteriparatide or its ingredients, and since August 2026 the label warns that anaphylaxis, angioedema (swelling under the skin) and hives have been reported with PTH medicines, including Yorvipath. In the 26-week PaTHway trial, the most common side effects on Yorvipath against placebo were injection site reactions (39% against 5%), vasodilatory symptoms such as dizziness, a drop in blood pressure on standing, palpitations or fainting (28% against 0%), headache (21% against 10%), diarrhea (10% against 5%), back pain (8% against 0%), high calcium (hypercalcemia, 8% against 0%) and throat pain (7% against 0%). Blood calcium went above the normal range at least once in 54% of patients on Yorvipath against 9.5% on placebo, and symptomatic high calcium happened in 8%, all within the first 3 months. The label also warns about serious high and low calcium, a possible risk of osteosarcoma (a bone cancer) seen in rats given PTH-type drugs, low blood pressure on standing, and digoxin toxicity if calcium runs high[1][3].
▸How is Palopegteriparatide taken?
Yorvipath is injected under the skin of the abdomen or front of the thigh once a day from a prefilled pen, rotating the site daily. The usual starting dose is 18 mcg, adjusted in 3 mcg steps, no more often than every 7 days going up or every 3 days going down, to a dose between 6 and 30 mcg that keeps blood calcium normal without active vitamin D or therapeutic calcium doses. On the day Yorvipath starts, active vitamin D and calcium supplements are cut back following a table in the label, and calcium to meet dietary needs may continue. Only 1 injection should be used for each daily dose. The first doses should be given sitting or lying down. A dose less than 12 hours late is taken right away; a dose more than 12 hours late is skipped. Each pen holds 14 days of doses and is kept in the refrigerator until first use, then at room temperature below 86°F for up to 14 days[1].
▸Is Palopegteriparatide FDA approved?
Yes, Palopegteriparatide (Yorvipath) is FDA approved (2024) for the treatment of Hypoparathyroidism.
▸Can I stop calcium and calcitriol when starting Yorvipath?
Your doctor lowers them in steps, not all at once. On the first day, calcitriol and calcium are reduced following a table in the label based on your blood calcium, and doses are adjusted again after calcium checks 7 to 10 days later. In the PaTHway trial, 95% of patients on Yorvipath no longer needed active vitamin D and 87% no longer needed therapeutic calcium doses at 26 weeks. Calcium to meet normal dietary needs may continue.
▸What are the side effects of Yorvipath?
In the PaTHway trial, the most common were injection site reactions (39% against 5% on placebo), dizziness or a drop in blood pressure on standing (28% against 0%), headache (21% against 10%), diarrhea, back pain, high calcium and throat pain. High calcium is most likely in the first 3 months or after a dose increase, which is why calcium is checked often. Since August 2026 the label also warns about allergic reactions.
▸How much does Yorvipath cost with insurance?
The price you pay depends on your plan. Ascendis says eligible patients with commercial insurance may pay as little as $5 a month through its Co-Pay Program, and uninsured or underinsured patients may qualify for $0 through the Ascendis Patient Assistance Program. People with Medicare, Medicaid or other government coverage cannot use the co-pay program. The A·S·A·P support line is 1-844-442-7236.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-08. YORVIPATH (palopegteriparatide) injection, for subcutaneous use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a1fa23fd-c434-443e-9a17-5750578c8602
- U.S. Food and Drug Administration · 2024-08-09. NDA 216490 approval letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216490Orig1s000ltr.pdf
- U.S. Food and Drug Administration · 2026-08-03. NDA 216490/S-011 supplement approval (hypersensitivity labeling for parathyroid hormone products). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216490Orig1s011ltr.pdf
- Ascendis Pharma · 2024-08-12. FDA Approves YORVIPATH (Palopegteriparatide) as the First and Only Treatment for Hypoparathyroidism in Adults. https://investors.ascendispharma.com/news-releases/news-release-details/fda-approves-yorvipathr-palopegteriparatide-first-and-only
- Journal of Bone and Mineral Research · 2023. Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial. https://doi.org/10.1002/jbmr.4726
- Journal of Clinical Endocrinology & Metabolism · 2025. Efficacy and Safety of TransCon PTH in Adults With Hypoparathyroidism: 52-Week Results From the Phase 3 PaTHway Trial. https://doi.org/10.1210/clinem/dgae693
- ClinicalTrials.gov. A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism (PaTHway). https://clinicaltrials.gov/study/NCT04701203
- Takeda · 2022-10-04. Takeda to Discontinue Manufacturing of NATPAR / NATPARA for Patients with Hypoparathyroidism at the End of 2024. https://www.takeda.com/en-us/newsroom/statements/2022/takeda-to-discontinue-manufacturing-of-natpar-natpara/
- Ascendis Pharma. Your Treatment Journey and Support With A·S·A·P. https://yorvipath.com/your-treatment-journey-and-support-with-asap/