Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glial growth factor 2/ Neuregulin 1β3 · 1 trial · 1 indication
Safety/ tolerability of single dose; cumulative safety over 6 months TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment.
| Arm | Type | Description |
|---|---|---|
| GGF2 | PLACEBO_COMPARATOR | Seven dosing cohorts: 2 patients randomized to receive 1 GGF2, 1 placebo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed |
| Name | Type | Description |
|---|---|---|
| Glial growth factor 2/ Neuregulin 1β3 | DRUG | - |
| Placebo | OTHER | - |
Inclusion Criteria: 1. Left ventricular ejection fraction (LVEF) between 10% and 40%. 2. Male or female, aged 18 to 75 years, inclusive. Exclusion Criteria: 1. Received any investigational agent or participation in any clinical study of an investigational agent or investigational therapy up to 30...
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Glial growth factor 2/ Neuregulin 1β3 is an investigational small molecule being developed for the treatment of heart failure. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and tolerability in patients.
Glial growth factor 2/ Neuregulin 1β3 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical research to evaluate this drug candidate for heart failure.
Glial growth factor 2/ Neuregulin 1β3 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The drug is still in early-stage clinical trials to assess its safety and tolerability in patients with heart failure.
Glial growth factor 2/ Neuregulin 1β3 has one completed clinical trial, identified as NCT01258387. This Phase 1 study, titled 'Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure,' enrolled 40 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.
Yes, Glial growth factor 2/ Neuregulin 1β3 is also known as GGF2. The clinical trial NCT01258387 refers to the drug as GGF2, and it is being studied for the treatment of heart failure. Both names refer to the same investigational drug candidate.