Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 5% Nu-3 gel
5% Nu-3 · 1 trial · 1 indication
Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug; number of SAEs per patient and cohort
The rate of reduction in CFUs by \>=2 logs per pathogen identified as typical and highly suspicious for being the cause of the infection, in each treatment group compared to placebo group at Day 7 compared to Day 0, and Day 14 compared to Day 0.
| Arm | Type | Description |
|---|---|---|
| 5% Nu-3 gel once daily | EXPERIMENTAL | The 5% Nu-3 gel is applied once per day and placebo is applied once per day. |
| 5% Nu-3 gel twice daily | EXPERIMENTAL | The 5% Nu-3 gel is applied twice per day. |
| 10% Nu-3 gel once daily | EXPERIMENTAL | The 10% Nu-3 gel is applied once per day and placebo is applied once per day. |
| 10% Nu-3 gel twice daily | EXPERIMENTAL | The 10% Nu-3 gel is applied twice per day. |
| Placebo | PLACEBO_COMPARATOR | The placebo is applied twice per day. |
| Name | Type | Description |
|---|---|---|
| 5% Nu-3 gel | DRUG | The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer. |
| 10% Nu-3 gel | DRUG | The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer. |
| Placebo | DRUG | Placebo gel is either applied once per day or twice per day to the infected ulcer. |
Inclusion Criteria: * 1\. Male and female subjects ≥18 years of age. 2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable. 3\. Non-hospitalized ambulatory subjects diagnosed with diabete...
5% Nu-3 is an investigational topical gel being developed for the treatment of diabetic foot infection. It is a small molecule therapy that is currently in Phase 2 clinical development. The drug is being studied in patients with infected diabetic foot ulcers.
5% Nu-3 is being developed by Lakewood-Amedex Biotherapeutics Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational gel for diabetic foot infection.
5% Nu-3 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial is ongoing to assess its effects in patients with diabetic foot infection.
5% Nu-3 is being studied in a Phase 2 clinical trial with the identifier NCT06020235, titled 'Nu-3 Gel for Infected Diabetic Foot Ulcers'. This randomized, double-blind, placebo-controlled trial is planned to enroll 60 participants aged 18 years and older.
Yes, 5% Nu-3 is also known as 5% Nu-3 gel. The drug is formulated as a topical gel and is being investigated for the treatment of diabetic foot infection in clinical trials.