Overview
ARX201 (PEG-ahGH) is a recombinant form of human growth hormone that has been modified using Ambrx’s patented ReCODE™ technology to achieve precise spatial positioning of the site of polyethylene glycol (PEG) attachment to human growth hormone, by biosynthetic incorporation of a chemically unique amino acid (ahGH). ARX201 has improved pharmacological properties, which should allow less frequent administration than the daily dosing regimen of currently available growth hormones.
Background
ARX201 (PEG-ahGH) is a recombinant form of human growth hormone that has been modified using Ambrx’s patented ReCODE™ technology to achieve precise spatial positioning of the site of polyethylene glycol (PEG) attachment to human growth hormone, by biosynthetic incorporation of a chemically unique amino acid (ahGH). ARX201 has improved pharmacological properties, which should allow less frequent administration than the daily dosing regimen of currently available growth hormones.
Indication
Investigated for use/treatment in growth hormone deficiencies/abnormalities.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/10/23 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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. | |||||