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Angal, lozenges

Phase 3

Sore Throat | Small molecule | ENT |Novartis AG|Last Updated: Mar 22, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment228

FDA Designations

No designations recorded

Clinical trial landscape

Angal, lozenges · 1 trial · 1 indication

Phase 3 1
NCT03095521A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore ThroatSore Throat
COMPLETED228 Analytics
PHASE3COMPLETED
A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat
Sore ThroatUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Without Sore Throat According to TSS Score
4 days

TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms 1. : insignificant symptom 2. : moderate symptom 3. : significant symptom fever 0 pts : \<37.5 °С; 1. pts : 37.5 to \<38.5 °С; 2. pts : 38.5 to \<39.5 °С; 3. pts : ≥ 39.5 °С. TSS total ranges are 0-15.

Secondary Endpoints

50% Reduction Tss SCORE
day 4
Change From Baseline in TSS Total Score
baseline and day 4
Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)
5 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALAngal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if this will happen earlier than 4th day of treatment.
Arm BACTIVE_COMPARATORANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if this will happen earlier than 5th day of treatment.

Interventions

NameTypeDescription
Angal, lozenges [menthol],DRUGAngal, administered per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution.
ANTI-ANGIN® FORMULADRUG0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia). Administered per 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Voluntarily signed informed consent for participation in this clinical study; 18 to 45 years old inclusive, male and female; * Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat; * Onset of first symptoms of the unco...

Countries:Russia
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Frequently asked questions about Angal, lozenges

What is Angal used for?

Angal lozenges are used for the treatment of sore throat. The drug is being developed by Novartis AG as a small molecule therapy in the ENT therapeutic area. It is currently in Phase 3 clinical development, though the single completed trial was not randomized or double-blind.

What does Angal target?

Angal lozenges are a small molecule therapy for sore throat. The specific molecular target has not been disclosed in available clinical trial information. The drug is being developed by Novartis AG and has completed a Phase 3 clinical trial in Russia.

Who makes Angal?

Angal lozenges are being developed by Novartis AG, which is publicly traded under the ticker NVS. The drug is in Phase 3 clinical development for the treatment of sore throat. A single clinical trial has been completed with 228 participants enrolled.

What phase is Angal in?

Angal lozenges are in Phase 3 clinical development for the treatment of sore throat. The drug has completed one Phase 3 trial, which was active-controlled and enrolled 228 participants. Angal is not yet approved and remains investigational.

What clinical trials is Angal in?

Angal lozenges have one completed clinical trial, NCT03095521, a Phase 3 study in Russia. The trial compared Angal lozenges with menthol against ANTI-ANGIN FORMULA lozenges in 228 patients with sore throat. The study was active-controlled and enrolled adults aged 18 years and older.

Is Angal the same as ANTI-ANGIN?

Angal lozenges are not the same as ANTI-ANGIN FORMULA lozenges. In the clinical trial NCT03095521, Angal was compared against ANTI-ANGIN FORMULA as an active control. The two products are distinct formulations being evaluated for efficacy and safety in treating sore throat.