Education
About Us
Working with TipRanks
Follow Us
Biocon Limited (IN:BIOCON)
:BIOCON
Biocon's Human Insulin R U-500, Humulin® R U-500 (Us Reference Product)
Healthy Volunteers
Phase I
Completed
Comparison of the Pharmacokinetic and Pharmacodynamic Properties of Biocon's Insulin R U-500 With Humulin® R U-500 (US Reference Product) in Healthy Subjects
Jun 07, 2022
―
Itolizumab
Acute-Graft-Versus-Host Disease, Graft Versus Host Disease, Agvhd, Gvhd, Acute Gvhd
Phase III
Terminated
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
Oct 01, 2021
―
Eq001
Coronavirus
Phase III
Withdrawn
A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19
Oct 21, 2020
―
Best Supportive Care (Bsc), Itolizumab Iv Infusion
COVID19, Acute Respiratory Distress Syndrome, Cytokine Release Syndrome
Phase II
Completed
Efficacy and Safety of Itolizumab in COVID-19 Complications
Jul 16, 2020
―
Tregopil
Type 1 Diabetes Mellitus (T1dm)
Phase I
Terminated
Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil
Oct 16, 2019
―
Itolizumab [Bmab 600]
Lupus Nephritis, Lupus Erythematosus
Phase I
Completed
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Sep 30, 2019
―
Humulin ®70/30, Biocon Insulin 70/30
Healthy Volunteer
Phase I
Completed
Comparison of Pharmacokinetic (PK) and Pharmacodynamic(PD) of Biocon Insulin 70/30 and Humulin® 70/30
Jul 04, 2019
―
Biocon Insulin N, Humulin® N
Healthy Volunteer
Phase I
Completed
Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N
Jun 29, 2019
―
Biocon Insulin R, Humulin®R
Healthy Volunteer
Phase I
Completed
Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R
Jun 29, 2019
―
Eq001
Asthma
Phase I
Completed
A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
Jun 27, 2019
―
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 Biocon Limited (BIOCON) have in its pipeline
BIOCON is currently developing the following drugs: Biocon's Human Insulin R U-500, Humulin® R U-500 (Us Reference Product), Itolizumab, Eq001. These drug candidates are in various stages of clinical development as the company works toward FDA approval.