Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ambroxol BIH1526 · 1 trial · 1 indication
Change from baseline to hour 3 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-3h)
| Arm | Type | Description |
|---|---|---|
| Ambroxol hydrochloride (BIH1526) | ACTIVE_COMPARATOR | One lozenge 20 mg on as-needed basis, up to 6 times per day |
| Placebo | PLACEBO_COMPARATOR | One lozenge on as-needed basis, up to 6 times per day |
| Name | Type | Description |
|---|---|---|
| ambroxol BIH1526 | DRUG | Pharmaceutical form: lozenges Route of administration: oromucosal |
| placebo | DRUG | Pharmaceutical form: lozenges Route of administration: oromucosal |
Inclusion criteria: * Adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to Visit 1. * Patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale. * Signed written informed consent. Exclusion ...
Ambroxol BIH1526 is an investigational small molecule being developed for the treatment of pharyngitis, which is inflammation of the throat. It is formulated as a hardboiled lozenge and is currently in Phase 3 clinical development. The drug is intended to provide relief for patients with acute pharyngitis.
Ambroxol BIH1526 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the efficacy and safety of this drug for the treatment of pharyngitis.
Ambroxol BIH1526 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will help determine whether the drug can be submitted for regulatory approval.
Ambroxol BIH1526 has been studied in one completed Phase 3 clinical trial with the identifier NCT03583658. The trial, titled 'Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis,' enrolled 390 participants in South Africa. It was a randomized, double-blind, placebo-controlled study involving adults aged 18 years and older.
Ambroxol BIH1526 is a small molecule that works by targeting the underlying mechanisms of pharyngitis. It is designed to reduce inflammation and provide symptomatic relief for acute throat pain. The drug is administered as a lozenge, allowing for local delivery to the affected area in the throat.
Ambroxol BIH1526 is a specific formulation of ambroxol, a well-known mucolytic agent. The BIH1526 designation refers to a particular version developed by Sanofi as a hardboiled lozenge for the treatment of pharyngitis. While it contains the same active ingredient, this formulation is being studied specifically for its efficacy in acute pharyngitis.