Overview
Teriparatide is a recombinant parathyroid hormone (PTH) analog and a potent osteoanabolic agent. It is made up of the first amino(N)-terminal 34 amino acids of the human PTH. First approved in the United States in November 2002 and in Europe in April 2003, teriparatide makes the first approved drug in a new category of osteoporosis therapy called anabolic therapy. Teriparatide is used in the treatment of osteoporosis in men and women.
Background
Teriparatide is a recombinant parathyroid hormone (PTH) analog and a potent osteoanabolic agent. It is made up of the first amino(N)-terminal 34 amino acids of the human PTH. First approved in the United States in November 2002 and in Europe in April 2003, teriparatide makes the first approved drug in a new category of osteoporosis therapy called anabolic therapy. Teriparatide is used in the treatment of osteoporosis in men and women.
Indication
Teriparatide is indicated:
Associated Conditions
- Osteoporosis
- Osteoporosis caused by Glucocorticoid Treatment
- Primary Osteoporosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/27 | Phase 3 | Not yet recruiting | |||
2024/10/16 | Phase 1 | Recruiting | QuadMedicine | ||
2024/08/16 | Phase 4 | Recruiting | |||
2024/02/20 | Phase 4 | ENROLLING_BY_INVITATION | |||
2023/12/11 | N/A | Recruiting | |||
2023/09/29 | Phase 4 | Recruiting | |||
2023/07/28 | Phase 1 | Active, not recruiting | |||
2023/05/19 | Not Applicable | Recruiting | |||
2021/12/20 | Phase 1 | Completed | |||
2021/12/09 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eli Lilly and Company | 0002-8400 | SUBCUTANEOUS | 250 ug in 1 mL | 4/29/2021 | |
| Apotex Corp. | 60505-6188 | SUBCUTANEOUS | 250 ug in 1 mL | 1/30/2024 | |
| Alvogen, Inc. | 47781-652 | SUBCUTANEOUS | 250 ug in 1 mL | 8/22/2017 | |
| Prasco Laboratories | 66993-495 | SUBCUTANEOUS | 250 ug in 1 mL | 11/17/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-1106 | SUBCUTANEOUS | 250 ug in 1 mL | 11/1/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/18/2022 | ||
Authorised | 8/27/2020 | ||
Authorised | 8/27/2020 | ||
Authorised | 1/11/2017 | ||
Authorised | 1/11/2017 | ||
Authorised | 3/24/2022 | ||
Authorised | 3/24/2022 | ||
Authorised | 1/12/2023 | ||
Authorised | 1/4/2017 | ||
Authorised | 1/4/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SONDELBAY INJECTION 20 MCG/80 MCL | SIN16802P | INJECTION, SOLUTION | 20 mcg/80μl | 6/1/2023 | |
| FORTEO INJECTION 20 mcg/80mcL | SIN12593P | INJECTION, SOLUTION | 750 mcg/3 ml | 9/27/2004 | |
| MEGAPTH-G SOLUTION FOR INJECTION 20 MCG/80MCL CARTRIDGE PACK | SIN17051P | INJECTION, SOLUTION | 20 mcg/80 mcl | 7/24/2024 | |
| MEGAPTH-G SOLUTION FOR INJECTION 20 MCG/80MCL PEN + CARTRIDGE PACK | SIN17052P | INJECTION, SOLUTION | 20 mcg/80 mcl | 7/24/2024 | |
| TERIPARATIDE-TEVA SOLUTION FOR INJECTION IN PRE-FILLED PEN 20 MCG/80 MCL | SIN17077P | INJECTION, SOLUTION | 20 mcg/80 mcL | 9/10/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Teriparatide Injection | 国药准字S20220015 | 生物制品 | 注射剂 | 4/19/2022 | |
| Teriparatide Injection | 国药准字S20240004 | 生物制品 | 注射剂 | 1/16/2024 | |
| Teriparatide Injection | 国药准字SJ20170032 | 生物制品 | 注射剂 | 9/10/2024 | |
| Teriparatide Injection | 国药准字S20240005 | 生物制品 | 注射剂 | 2/6/2024 | |
| Recombinant Teriparatide for Injection | 国药准字S20190037 | 生物制品 | 注射剂 | 9/29/2019 | |
| Recombinant Teriparatide for Injection | 国药准字S20170004 | 生物制品 | 注射剂 | 11/22/2021 |
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 |
|---|---|---|---|---|---|
| RITOSA teriparatide 250 microgram/mL solution for injection pre-filled cartridge | 408423 | Medicine | A | 5/2/2024 | |
| TERROSA teriparatide (rbe) 250 microgram/mL solution for injection cartridge in a pre-filled pen | 405710 | Medicine | A | 5/16/2023 | |
| TERIPARATIDE LUPIN teriparatide 250 microgram per mL solution for injection pre-filled cartridge | 373604 | Medicine | A | 4/6/2023 | |
| CIPLA TERIPARATIDE teriparatide 250 microgram/mL solution for injection cartridge | 392435 | Medicine | A | 7/23/2024 | |
| TERIPARATIDE SUN teriparatide 250 microgram/mL solution for injection pre-filled cartridge | 408420 | Medicine | A | 5/2/2024 | |
| TERIPARATIDE LAPL teriparatide 250 microgram per mL solution for injection pre-filled cartridge | 373602 | Medicine | A | 4/6/2023 | |
| FORTEO teriparatide (rbe) 250 microgram solution for injection cartridge | 80333 | Medicine | A | 5/22/2003 | |
| TERIPARATIDE RBX teriparatide250 microgram/mL solution for injection pre-filled cartridge | 408422 | Medicine | A | 5/2/2024 |