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Kyntra Bio (KYNB) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Fg-3246 | Metastatic Castration-Resistant Prostate Cancer | Phase II | Not Yet Recruiting | A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Feb 19, 2025 | ― |
| Roxadustat, Sepo® | Chemotherapy Induced Anemia | Phase III | Completed | A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies | Mar 19, 2022 | ― |
| Corticosteroids, Pamrevlumab | Duchenne Muscular Dystrophy | Phase III | Terminated | Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD | Nov 12, 2020 | ― |
| Roxadustat | Anemia Associated With Chronic Kidney Disease | Phase III | Withdrawn | Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD | Nov 03, 2020 | ― |
| Roxadustat | Anemia Associated With End Stage Renal Disease | Phase III | Completed | Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants | Jul 21, 2020 | ― |
| Pamrevlumab | Covid-19 | Phase II | Terminated | Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease | Jun 12, 2020 | ― |
| Pamrevlumab | Idiopathic Pulmonary Fibrosis | Phase III | Terminated | Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) | Jun 03, 2020 | ― |
| Roxadustat | Anemia Associated With End Stage Renal Disease (Esrd) | Phase III | Completed | Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants | May 27, 2020 | ― |
| Corticosteroids, Pamrevlumab | Duchenne Muscular Dystrophy | Phase III | Terminated | Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD) | Apr 29, 2020 | ― |
| Roxadustat | Chemotherapy Induced Anemia | Phase II | Completed | Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia | Aug 30, 2019 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Fg-3246 | Phase II | Metastatic Castration-Resistant Prostate Cancer | Not Yet Recruiting | A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Feb 19, 2025 | ― |
| Roxadustat, Sepo® | Phase III | Chemotherapy Induced Anemia | Completed | A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies | Mar 19, 2022 | ― |
| Corticosteroids, Pamrevlumab | Phase III | Duchenne Muscular Dystrophy | Terminated | Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD | Nov 12, 2020 | ― |
| Roxadustat | Phase III | Anemia Associated With Chronic Kidney Disease | Withdrawn | Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD | Nov 03, 2020 | ― |
| Roxadustat | Phase III | Anemia Associated With End Stage Renal Disease | Completed | Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants | Jul 21, 2020 | ― |
| Pamrevlumab | Phase II | Covid-19 | Terminated | Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease | Jun 12, 2020 | ― |
| Pamrevlumab | Phase III | Idiopathic Pulmonary Fibrosis | Terminated | Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) | Jun 03, 2020 | ― |
| Roxadustat | Phase III | Anemia Associated With End Stage Renal Disease (Esrd) | Completed | Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants | May 27, 2020 | ― |
| Corticosteroids, Pamrevlumab | Phase III | Duchenne Muscular Dystrophy | Terminated | Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD) | Apr 29, 2020 | ― |
| Roxadustat | Phase II | Chemotherapy Induced Anemia | Completed | Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia | Aug 30, 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 Kyntra Bio, Inc. (KYNB) have in its pipeline
Kyntra Bio KYNB is currently developing the following drugs: Fg-3246, Roxadustat, Sepo®, Corticosteroids, Pamrevlumab, Roxadustat, Pamrevlumab, Pamrevlumab + Gemcitabine + Nab-Paclitaxel Or Pamrevlumab + Folfirinox, Fg-4592, Roxadustat, Da, Asp1517, Lanthanum Carbonate Hydrate, Darbepoetin Alfa, Roxadustat, Asp1517, Asp1517, Kremezin®, Fg-4592, Epoetin Alfa, Epoetin Alfa, Darbepoetin Alfa, Iron, Roxadustat, Epoetin Alfa, Roxadustat, Gemcitabine, Nab-paclitaxel, Fg-3019, Pamrevlumab, Sub-Study: Pirfenidone, Sub-Study: Nintedanib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.