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Xeris Pharmaceuticals (XERS)
NASDAQ:XERS
Levothyroxine Sodium
Hypothyroidism
Phase II
Completed
Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
Mar 28, 2023
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Pram9, Regular Insulin + Pramlintide, Regular Insulin
Diabetes Mellitus, Type 1, Insulin-Dependent Diabetes Mellitus
Phase II
Completed
Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
Aug 28, 2019
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Glucagon Rtu Injection With Insulin Pump Reduction, Vehicle For Glucagon Rtu Injection With Insulin Pump Reduction, Glugaon Rtu Injection Without Insulin Pump Reduction
Hypoglycemia
Phase II
Completed
Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D
Feb 12, 2019
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Glucagon Rtu
Hyperinsulinemic Hypoglycemia
Phase II
Completed
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
Dec 07, 2018
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G-Pen, Novo Glucagon
Type 1 Diabetes Mellitus, Insulin Hypoglycemia, Severe Hypoglycemia
Phase III
Completed
G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
Nov 08, 2018
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Glucagon
Diabetes Mellitus, Type 1, Hypoglycemia Unawareness
Phase II
Terminated
Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses
Mar 25, 2018
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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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Glucagon
Diabetes Mellitus, Type 1
Phase III
Completed
Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
Mar 16, 2017
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Glucagon
Congenital Hyperinsulinism
Phase II
Completed
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
Oct 14, 2016
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G-Pump™ (Glucagon Infusion)
Hypoglycemia, Complications Of Bariatric Procedures
Phase II
Completed
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
Mar 30, 2016
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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 Xeris Pharmaceuticals (XERS) have in its pipeline
XERS is currently developing the following drugs: Levothyroxine Sodium, Pram9, Regular Insulin + Pramlintide, Regular Insulin, Glucagon Rtu Injection With Insulin Pump Reduction, Vehicle For Glucagon Rtu Injection With Insulin Pump Reduction, Glugaon Rtu Injection Without Insulin Pump Reduction. These drug candidates are in various stages of clinical development as the company works toward FDA approval.