Overview
Parathyroid hormone (PTH) is a single-chain polypeptide composed of 84 amino acids. Available as Preotact, it is an identical form of human recombinant hormome which produced as a fusion protein undergoeing post-translational processing involving the cleavage of the OmpA leader sequence, leaving the mature protein as a single-chain 84 amino-acids polypeptide (9.4 kDa). Preotact is used in the treatment of osteoporosis in postmenopausal women at high risk of osteoporotic fractures and is marketed in Europe by Nycomed. Preos is a registered trade mark owned by NPS Pharmaceuticals, Inc. The name Preos and the New Drug Application is pending approval by the U.S. Food and Drug Administration (FDA).
Indication
For use/treatment in osteoporosis.
Associated Conditions
- Hypocalcemia
- Hypoparathyroidism
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/05/24 | Phase 3 | Recruiting | Visen Pharmaceuticals (Shanghai) Co., Ltd. | ||
2021/11/30 | Phase 1 | Completed | |||
2019/03/18 | Phase 3 | Withdrawn | |||
2017/05/12 | Phase 1 | Completed | |||
2016/09/22 | Phase 4 | Completed | |||
2016/05/25 | Phase 1 | Completed | |||
2011/12/29 | Phase 4 | Completed | |||
2011/11/08 | Phase 3 | Completed | |||
2011/10/19 | Phase 3 | Completed | |||
2011/04/11 | Phase 1 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. | 68875-0202 | SUBCUTANEOUS | 25 ug in 0.08 mL | 2/28/2023 | |
| Takeda Pharmaceuticals America, Inc. | 68875-0204 | SUBCUTANEOUS | 75 ug in 0.08 mL | 2/28/2023 | |
| Takeda Pharmaceuticals America, Inc. | 68875-0205 | SUBCUTANEOUS | 100 ug in 0.08 mL | 2/28/2023 | |
| Takeda Pharmaceuticals America, Inc. | 68875-0203 | SUBCUTANEOUS | 50 ug in 0.08 mL | 2/28/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/24/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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