Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hylenex · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | NO_INTERVENTION | IV Morphine |
| 2 | EXPERIMENTAL | SC Morphine with Hylenex |
| 3 | ACTIVE_COMPARATOR | SC Morphine with Saline |
| Name | Type | Description |
|---|---|---|
| Hylenex | DRUG | Add Hylenex to SC injection of Morphine |
Inclusion Criteria: 1. Males or females at least 18 years of age who are patients of San Diego Hospice \& Palliative Care or recruited through San Diego Hospice \& Palliative Care or the UCSD Center for Pain and Palliative Medicine. 2. During the treatment days of the study, on opioid therapy other...
Hylenex is an investigational drug being studied for use in pain and in healthy volunteers. It is a small molecule developed by Halozyme Therapeutics, Inc. (NASDAQ: HALO). Hylenex is currently in clinical development and is not approved by the FDA.
Hylenex is a recombinant human hyaluronidase, an enzyme that breaks down hyaluronan, a component of the extracellular matrix. By depolymerizing hyaluronan, it increases tissue permeability, which can facilitate the dispersion and absorption of co-administered drugs.
Hylenex is developed by Halozyme Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker HALO. Halozyme is responsible for the clinical development and manufacturing of Hylenex.
Hylenex has completed a Phase 1 clinical trial and a Phase 3 clinical trial. The Phase 1 trial evaluated subcutaneous injection of a viscous antibody solution with recombinant human hyaluronidase in healthy volunteers, and the Phase 3 trial studied the INFUSE Morphine regimen for pain.
Hylenex has been studied in two completed clinical trials. NCT00435604 was a Phase 1 study in healthy volunteers evaluating subcutaneous injection of a viscous antibody solution with recombinant human hyaluronidase. NCT00593281 was a Phase 3 study in the United States for pain, called the INFUSE Morphine Study.
Yes, Hylenex is a form of recombinant human hyaluronidase. It is an enzyme that temporarily breaks down hyaluronan in the subcutaneous space, which can enhance the absorption of injected fluids and medications.