Approval Probability
TA Base Rate
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Menadione · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Subjects will be treated if, after starting treatment with an EGFRi, acute signs and symptoms of rash on the face/neck and/or upper chest emerge, that are suspected of being related to the EGFRi treatment. |
| Group 2 | EXPERIMENTAL | Subjects will receive pre-emergent rash treatment starting 1 day prior to beginning EGFRi therapy |
| Name | Type | Description |
|---|---|---|
| Menadione Topical Lotion | DRUG | Menadione Lotion will be applied topically twice a day; beginning when the rash appears during EGFRi therapy. |
Inclusion Criteria: 1. Male or female subjects at least 18 years old; 2. Have been prescribed an approved EGFRI to treat cancer and expect to begin this treatment within 14 days (i.e., any EGFRI that is approved for the treatment of cancer at the time of subject enrollment); 3. For Group 1: Agree t...
Menadione is an investigational small molecule being developed for EGFR Inhibitor-associated Rash, a dermatologic condition. It is formulated as a topical lotion and is intended to treat rash that occurs in patients receiving epidermal growth factor receptor inhibitors. The drug is still in clinical development and is not approved.
Menadione is being developed by Assertio Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ASRT. The company is conducting clinical research on the topical lotion formulation for EGFR Inhibitor-associated Rash.
Menadione is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a safety, tolerability, and systemic absorption study. The drug is investigational and has not been approved by regulatory authorities.
Menadione has one completed clinical trial, NCT00656786, titled 'Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash.' This Phase 1 study enrolled 18 participants in the United States and Canada and was a randomized, double-blind, controlled trial.
Menadione is a small molecule, but its specific molecular target for treating EGFR Inhibitor-associated Rash has not been disclosed. The drug is applied topically as a lotion, and its mechanism of action in this indication is not publicly detailed.
Menadione is also known as vitamin K3, a synthetic form of vitamin K. In the context of this development program, it is being studied as a topical treatment for EGFR Inhibitor-associated Rash. The drug is in Phase 1 clinical development and is not approved.