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SGS SA (CH:SGSN)
:SGSN
Test Product (T):Chf 5993 Bdp/Ff/Gb 200/6/12.5 Μg Pmdi, Reference Product 1 (R1): Chf 5993 Bdp/Ff/Gb 100/6/12.5 Μg Pmdi, Reference Product 2 (R2): Bdp Hfa (Qvar Redihaler®, Bdp 80 Μg)
Asthma
Phase I
Completed
Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR®
Apr 14, 2023
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G-Pen, Lilly Glucagon
Type 1 Diabetes Mellitus, Insulin Hypoglycemia, Severe Hypoglycemia
Phase III
Completed
G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes
Feb 13, 2018
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Chf 6001 Dose1, Chf 6001 Dose2
Copd
Phase II
Completed
Pharmacodynamics, Pharmacokinetics and Safety of Two Doses of CHF6001 DPI in Subjects With Moderate, Severe COPD
Dec 02, 2016
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Glpg2451 Single Dose
Healthy
Phase I
Completed
A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Female Subjects
May 13, 2016
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Pacritinib
Myelofibrosis
Phase I
Completed
PK of Pacritinib in Patients With Mild, Moderate, Severe Renal Impairment and ESRD Compared to Healthy Subjects
May 03, 2016
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Pacritinib
Myelofibrosis
Phase I
Completed
Determine Pacritinib Pharmacokinetics in Impaired Hepatic Patients and Healthy Subjects
May 03, 2016
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Olesoxime (Tro19622)
Relapsing Remitting Multiple Sclerosis
Phase I
Completed
Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.
Feb 12, 2013
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does SGS SA (SGSN) have in its pipeline
SGSN is currently developing the following drugs: Test Product (T):Chf 5993 Bdp/Ff/Gb 200/6/12.5 Μg Pmdi, Reference Product 1 (R1): Chf 5993 Bdp/Ff/Gb 100/6/12.5 Μg Pmdi, Reference Product 2 (R2): Bdp Hfa (Qvar Redihaler®, Bdp 80 Μg), G-Pen, Lilly Glucagon, Chf 6001 Dose1, Chf 6001 Dose2. These drug candidates are in various stages of clinical development as the company works toward FDA approval.