Drug intelligence / Profile preview

Sinupret extract

Development stage
Phase 3
Lead developer
Bionorica
Modality
Small Molecules
Administration
Oral
01

Overview

BNO 1016 (marketed as Sinupret extract) is a standardized, high-dose herbal dry extract developed by Bionorica SE for the treatment of acute rhinosinusitis (ARS). It is composed of a fixed combination of five plant-based ingredients: gentian root (*Gentiana lutea*), primrose flowers (*Primula veris*), sorrel herb (*Rumex acetosa*), elder flowers (*Sambucus nigra*), and vervain herb (*Verbena officinalis*). The drug is administered orally at a dose of 160 mg three times daily. Its therapeutic effect is driven by a dual mechanism: it acts as a secretolytic by stimulating chloride secretion through the activation of the cystic fibrosis transmembrane conductance regulator (CFTR), thereby enhancing mucociliary clearance, and it provides anti-inflammatory effects that reduce nasal mucosal edema. Clinical efficacy was established in the ARhiSi-1 and ARhiSi-2 Phase 3 trials, which demonstrated a significant reduction in the Major Symptom Score (MSS) compared to placebo. BNO 1016 is recommended in the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) as an evidence-based alternative to antibiotics for managing viral and post-viral acute rhinosinusitis.

Brand names
Sinupret extract
Other names
BNO 1016 dry extractBNO1016 dry extractBNO-1016 dry extractSinupret eXtract
02

Targets

ANO1 (Anoctamin-1)

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