Recent Updates
Recently added Catalysts

Ambroxol

Phase 2

Cough | Small molecule | Other |Sanofi|Last Updated: Jun 20, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03415269A Study of the Effect of 20 mg Ambroxol Hydrochloride on Acute Cough.PHASE2 COMPLETED 14Feb 15, 2018Apr 19, 2018Jun 20, 20191 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Cough reflex sensitivity
8 hours

To assess the effect of single dose of 20 mg ambroxol lozenge on cough reflex sensitivity (quatified by recording the concenteration of cough stimulant evoking 2 (C2) and 5 (C5 ) coughs) to four different types of challenge agents in acute cough associated with URTI.

Secondary Endpoints
Severity of cough Visual analogue scale (VAS)
90 min post dose
Urge to cough Visual analogue scale (VAS)
90 min post dose
Change in cough reflex sensitivity from during acute cough to post symptom recovery
up tp 1 month
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
20 mg ambroxolEXPERIMENTAL20 mg ambroxol lozenge delivered once on one day
Interventions
NameTypeDescription
Ambroxol HydrochlorideDRUGsingle lozenge of 20mg ambroxol
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Be informed of the nature of the study and have provided written informed voluntary consent; 2. Be able to speak, read, and understand English; 3. Be males or females, of any race, between 18 and 80 years of age, inclusive; 4. Subject has an acute cough and other symptoms con...

Countries:United Kingdom
Unlock Eligibility Criteria