Overview
Lonapegsomatropin, also known as TransCon hGH or ACP 001, is a methoxypegylated prodrug of human growth hormone (somatropin) indicated for the treatment of children 1 year and older, weighing at least 11.5 kg, with growth failure due to insufficient growth hormone secretion. Unlike somatropin, which requires daily dosing, lonapegsomatropin can be administered as a single weekly dose. Lonapegsomatropin was granted FDA approval on 25 August 2021. It was later approved by the European Commission on 13 January 2022.
Indication
In the US, lonepegsomatropin is indicated in the treatment of growth failure due to inadequate growth hormone secretion in patients one year and older who weigh at least 11.5 kg. In Europe, lonepegsomatropin is indicated to treat growth failure in children and adolescents aged from three years up to 18 years due to insufficient endogenous growth hormone secretion or growth hormone deficiency.
Associated Conditions
- Growth Failure
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/29 | Phase 2 | Active, not recruiting | |||
2023/01/19 | Phase 2 | Active, not recruiting | |||
2021/12/29 | Phase 3 | Completed | |||
2020/11/04 | Phase 3 | Completed | |||
2013/09/23 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ascendis Pharma Endocrinology, Inc. | 73362-006 | SUBCUTANEOUS | 5.2 mg in 1 1 | 10/28/2022 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-005 | SUBCUTANEOUS | 4.3 mg in 1 1 | 10/28/2022 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-010 | SUBCUTANEOUS | 11 mg in 1 1 | 10/28/2022 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-008 | SUBCUTANEOUS | 7.6 mg in 1 1 | 10/28/2022 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-003 | SUBCUTANEOUS | 3 mg in 1 1 | 10/28/2022 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-011 | SUBCUTANEOUS | 13.3 mg in 1 1 | 10/28/2022 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-007 | SUBCUTANEOUS | 6.3 mg in 1 1 | 10/28/2022 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-009 | SUBCUTANEOUS | 9.1 mg in 1 1 | 10/28/2022 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-004 | SUBCUTANEOUS | 3.6 mg in 1 1 | 10/28/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/11/2022 |
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
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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