Recombinant human parathyroid hormone
| Clinical data | |
|---|---|
| Trade names | Preotact, Natpara, Natpar |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a617013 |
| License data | |
| Routes of administration | Subcutaneous |
| Drug class | Hormonal agent |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C408H674N126O126S2 |
| Molar mass | 9424.76 g·mol−1 |
Recombinant human parathyroid hormone is an artificially manufactured form of the parathyroid hormone used to help treat hypoparathyroidism (under-active parathyroid glands) and osteoporosis.[1][5][6]
Recombinant human parathyroid hormone (Preotact) received market authorization in the European Union in April 2006 to treat osteoporosis in postmenopausal women at high risk of fractures. Preotact marketing authorisation was later voluntarily withdrawn in 2014 by the holder NPS Pharma.[3] FDA approval (as Preos) was not granted in the US for the same indication due to hypercalcemia and injection device issues.[7]
Recombinant human parathyroid hormone (Natpara) was approved for medical use in the United States in January 2015, and received (as Natpar) conditional market authorization in the European Union in February 2017 as orphan drug.[2][4] On 2019 Natpara was recalled in the US due to rubber particle issues emerging from daily use of the cartridge.[8] Takeda announced in 2022 its decision to stop manufacturing Natpara/Natpar globally at the end of 2024.[9]
- ^ a b "Natpara (parathyroid hormone)- parathyroid hormone injection, powder, lyophilized, for solution". DailyMed. Retrieved 8 May 2021.
- ^ a b "FDA approves Natpara to control low blood calcium levels in patients with hypoparathyroidism". U.S. Food and Drug Administration (FDA) (Press release). Archived from the original on 30 January 2015. Retrieved 30 January 2015. This article incorporates text from this source, which is in the public domain.
- ^ a b "Preotact EPAR". European Medicines Agency. 17 September 2018. Retrieved 3 July 2020.
- ^ a b "Natpar EPAR". European Medicines Agency. 18 December 2013. Retrieved 28 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ Kim ES, Keating GM (July 2015). "Recombinant Human Parathyroid Hormone (1-84): A Review in Hypoparathyroidism". Drugs. 75 (11): 1293–303. doi:10.1007/s40265-015-0438-2. PMID 26177893. S2CID 2074875.
- ^ Watts NB, Bilezikian JP, Bone HG, Clarke BL, Denham D, Levine MA, et al. (March 2023). "Long-Term Safety and Efficacy of Recombinant Human Parathyroid Hormone (1-84) in Adults With Chronic Hypoparathyroidism". Journal of the Endocrine Society. 7 (5): bvad043. doi:10.1210/jendso/bvad043. PMC 10119703. PMID 37091306.
- ^ PharmaTimes (13 June 2006). "NPS plummets on decision to halt Preos development - PharmaTimes". pharmatimes.com. Retrieved 24 April 2025.
- ^ "Takeda Issues US Recall of NATPARA® (parathyroid hormone) for Injection Due to the Potential for Rubber Particulate". www.takeda.com. Retrieved 24 April 2025.
- ^ "Takeda to Discontinue Manufacturing of NATPAR® / NATPARA® for Patients with Hypoparathyroidism at the End of 2024". www.takeda.com. Retrieved 24 April 2025.