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Biocon Limited (BIOCON) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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| Eq001 | Coronavirus | Phase III | Withdrawn | A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19 | Oct 21, 2020 | ― |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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Biocon's Human Insulin R U-500, Humulin® R U-500 (Us Reference Product) | Phase I | Healthy Volunteers | 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 | Phase III | Acute-Graft-Versus-Host Disease, Graft Versus Host Disease, Agvhd, Gvhd, Acute Gvhd | 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 | Phase III | Coronavirus | 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 | Phase II | COVID19, Acute Respiratory Distress Syndrome, Cytokine Release Syndrome | Completed | Efficacy and Safety of Itolizumab in COVID-19 Complications | Jul 16, 2020 | ― |
| Tregopil | Phase I | Type 1 Diabetes Mellitus (T1dm) | Terminated | Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil | Oct 16, 2019 | ― |
| Itolizumab [Bmab 600] | Phase I | Lupus Nephritis, Lupus Erythematosus | 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 | Phase I | Healthy Volunteer | 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 | Phase I | Healthy Volunteer | Completed | Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N | Jun 29, 2019 | ― |
| Biocon Insulin R, Humulin®R | Phase I | Healthy Volunteer | Completed | Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R | Jun 29, 2019 | ― |
| Eq001 | Phase I | Asthma | 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
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 (IN:BIOCON) have in its pipeline
Biocon Limited IN:BIOCON is currently developing the following drugs: Biocon's Human Insulin R U-500, Humulin® R U-500 (Us Reference Product), Itolizumab, Eq001, Best Supportive Care (Bsc), Itolizumab Iv Infusion, Tregopil, Itolizumab [Bmab 600], Humulin ®70/30, Biocon Insulin 70/30, Biocon Insulin N, Humulin® N, Biocon Insulin R, Humulin®R, In-105 (Insulin Tregopil), Insulin Aspart, Insulin Tregopil, In-105, Insulin Lispro Injection. These drug candidates are in various stages of clinical development as the company works toward FDA approval.