Approval Probability
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TEPEZZA · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1: TEPEZZA Dose A SubQ | EXPERIMENTAL | Participants will receive Dose A of TEPEZZA administered SubQ. |
| Cohort 2: TEPEZZA Dose B SubQ | EXPERIMENTAL | Participants will receive Dose B of TEPEZZA administered SubQ. |
| Cohort 3: TEPEZZA Dose B Intravenously (IV) | EXPERIMENTAL | Participants will receive Dose B of TEPEZZA administered IV. |
| Cohort 4: TEPEZZA Dose B and EDP SubQ | EXPERIMENTAL | Participants will receive coadministered doses of TEPEZZA Dose B and EDP SubQ. |
| Name | Type | Description |
|---|---|---|
| TEPEZZA | DRUG | Administered as a SubQ injection or IV injection. |
| EDP | DRUG | Administered as a SubQ injection. |
Inclusion Criteria: * The participant is able to provide written informed consent. * The participant is male or female 18 to 55 years of age, inclusive. * The participant has a body mass index (BMI) between 21 to 30 kg/m\^², inclusive, and a minimum weight of 55 kg at Screening. * The participant i...
TEPEZZA is a small molecule being studied for bioavailability and bioequivalence. A completed Phase 1 clinical trial evaluated subcutaneous administration of TEPEZZA in healthy adults to assess these parameters. The drug is investigational and not approved for any indication.
TEPEZZA is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The company is conducting clinical research on this small molecule drug candidate.
TEPEZZA is in Phase 1 clinical development. A single Phase 1 study has been completed, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval.
TEPEZZA has one completed clinical trial, NCT06563856, titled 'A Study of TEPEZZA Subcutaneous Administration in Healthy Adults.' This Phase 1 study enrolled 37 participants in the United States and evaluated bioavailability and bioequivalence.
TEPEZZA is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on bioavailability and bioequivalence in healthy volunteers, and the drug has not yet progressed to later-stage studies.