Recent Updates
Recently added Catalysts

Angal S

Phase 3

Sore Throat | Small molecule | ENT |Novartis AG|Last Updated: Mar 21, 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment229

FDA Designations

No designations recorded

Clinical trial landscape

Angal S · 1 trial · 1 indication

Phase 3 1
NCT03095508Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore ThroatSore Throat
COMPLETED229 Analytics
PHASE3COMPLETED
Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat
Sore ThroatUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS)
4 Days

The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15.

Secondary Endpoints

Percentage of Participants With a ≥50% TSS Total Score Reduction
4 days
Change From Baseline in TSS Total Score
4 days
Number of Participants Who Fully Recovered
Group A: 4 days Group B: 5 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Angal S (Arm A)EXPERIMENTALPatients received Angal S, topical spray \[Menthol\], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
ANTI-ANGIN® FORMULA (Arm B)ACTIVE_COMPARATORPatients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution

Interventions

NameTypeDescription
Angal S, topical spray [Menthol]DRUG0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
ANTI-ANGIN® FORMULA, topical metered sprayDRUG0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as one to two consecutive presses on the actuator button, up to 6 times per day, , for a maximum 5 days or until full illness resolution
Unlock Study Design Details

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 un...

Countries:Russia
Unlock Eligibility Criteria

Frequently asked questions about Angal S

What is Angal S used for?

Angal S is a small molecule drug developed by Novartis AG for the treatment of sore throat. It is intended for patients with uncomplicated acute infectious and inflammatory diseases of the pharynx accompanied by a sore throat. The drug is administered as a topical spray.

Who makes Angal S?

Angal S is developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. The drug is being investigated for the treatment of sore throat and is currently in Phase 3 clinical development.

What phase is Angal S in?

Angal S is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 clinical trial has been completed to evaluate its efficacy and safety in patients with sore throat.

What clinical trials is Angal S in?

Angal S has one completed Phase 3 clinical trial registered as NCT03095508. This study compared the efficacy and safety of Angal S topical spray with ANTI-ANGIN FORMULA topical metered spray in 229 patients with uncomplicated acute infectious and inflammatory diseases of the pharynx accompanied by a sore throat.

Is Angal S the same as ANTI-ANGIN FORMULA?

No, Angal S is not the same as ANTI-ANGIN FORMULA. In clinical trial NCT03095508, Angal S was compared against ANTI-ANGIN FORMULA as an active control. The trial was designed to assess the comparative efficacy and safety of the two topical sprays in treating sore throat.