Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
velafermin · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | placebo |
| 2 | EXPERIMENTAL | 30 mcg/kg velafermin |
| 3 | EXPERIMENTAL | 10 mcg/kg velafermin |
| 4 | EXPERIMENTAL | 60 mcg/kg velafermin |
| Name | Type | Description |
|---|---|---|
| velafermin | DRUG | administered intravenously as 100mL single dose over 15 minutes on day 1 |
| placebo | DRUG | administered intravenously as 100mL single dose over 15 minutes on day 1 |
Inclusion Criteria: * Age 18 years or older * Patients with multiple myeloma or lymphoma receiving myeloablative CT with or without TBI that require autologous stem cell support. The CT regimens are limited to high dose melphalan (200 mg/m2) as a single agent, BEAM, or TBI with cyclophosphamide or ...
Velafermin is an investigational small molecule being developed for the prevention of oral mucositis, a painful inflammation and ulceration of the mouth lining. It is intended for patients with oral mucositis and stomatitis. The drug is currently in clinical development and has not been approved by the FDA.
Velafermin is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLDX. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the prevention of oral mucositis.
Velafermin is in Phase 2 clinical development. It has completed a Phase 2 trial, but it remains investigational and is not yet approved for commercial use. The drug is being studied for the prevention of oral mucositis, with no active trials currently listed.
Velafermin has one completed clinical trial, identified as NCT00323518, titled "A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis." This Phase 2 study enrolled 390 participants in the United States and was randomized, double-blind, and placebo-controlled.
No, velafermin is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed Phase 2 trial, NCT00323518, evaluated the drug for the prevention of oral mucositis, but the drug has not received regulatory approval.