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Clinical trials
catalyst calendar across sponsors →Studies where KYNB is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
41 interventional · 21 with posted results
Held by 2 tracked-famous managers (TWO SIGMA INVESTMENTS, LP, RENAISSANCE TECHNOLOGIES LLC) · FINRA short interest 16.9 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study to Investigate the Efficacy and Safety of Roxadustat (FG-4592) for Treating Anemia in Participants With Myelodysplastic Syndromes (MDS)NCT07722988Percentage of Participants With Red Blood Cell-transfusion Independence (RBC-TI) Over Any Consecutive 56-day PeriodRandomized · Quadruple-masked · Treatment | Phase 3 | Not yet recruiting | Drug: Roxadustat, Placebo | Myelodysplastic Syndromes | 201 | Sep 2030 | ≤ 1,503 d | 2026-07-23 |
| A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)NCT06842498Radiographic Progression-free Survival (rPFS) By Investigator Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) CriteriaRandomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: FG-3246 | Metastatic Castration-Resistant Prostate Cancer | 75 | 2028-03-31 | in 590 d | 2026-08-17 |
| Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic CancerNCT03941093results2024-11-05Overall SurvivalRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX, Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX | Pancreatic Cancer Non-resectable | 284 | 2024-06-11actual | — | 2024-11-05 |
| Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)NCT04419558results2024-08-12DB Period: Change From Baseline in FVC at Week 48Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor Decision | Drug: Pamrevlumab, Placebo | Idiopathic Pulmonary Fibrosis | 372 | 2023-09-04actual | — | 2024-08-12 |
| Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMDNCT04632940results2024-08-26Change From Baseline in North Star Ambulatory Assessment (NSAA) Total Score at Week 52Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study did not meet its primary endpoint. | Drug: Pamrevlumab, Placebo, Corticosteroids | Duchenne Muscular Dystrophy | 73 | 2023-06-12actual | — | 2024-08-26 |
| A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid MalignanciesNCT05301517Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: SEPO®, Roxadustat | Chemotherapy Induced Anemia | 159 | 2023-04-03actual | — | 2023-06-06 |
| Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)NCT03955146results2024-09-19DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study did not meet its primary endpoint. | Drug: Pamrevlumab, Placebo | Idiopathic Pulmonary Fibrosis | 393 | 2023-03-20actual | — | 2024-09-19 |
| Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion BurdenNCT03263091results2024-08-01OL and OL High-EPO Components: Number of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) ≥8 Weeks (≥56 Consecutive Days) Since First Dose in the First 28 Weeks of TreatmentRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study did not meet its primary efficacy endpoint. | Drug: Roxadustat, Placebo | Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Anemia | 184 | 2023-03-09actual | — | 2024-08-01 |
| Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD)NCT04371666results2024-03-12Change From Baseline in the Total Score of Performance of Upper Limb (PUL) 2.0 Version at Week 52Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study did not meet its primary endpoint. | Drug: Pamrevlumab, Placebo, Corticosteroids | Duchenne Muscular Dystrophy | 98 | 2023-02-13actual | — | 2024-03-12 |
| Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)NCT03303066Percentage of Participants With a Hemoglobin (Hb) Response to FG-4592 Without TransfusionRandomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: FG-4592, Placebo | Anemia, Myelodysplastic Syndrome | 43 | 2023-01-11actual | — | 2023-05-03 |
| Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKDNCT04621331Proportion of patients with mean Hb ≥ 11.0 g/dLOpen-label · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Sponsor's decision | Drug: Roxadustat | Anemia Associated With Chronic Kidney Disease | 0 | 2022-05-23actual | — | 2022-07-05 |
| A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic CancerNCT02210559results2023-03-02Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: FG-3019, Gemcitabine, Nab-paclitaxel | Pancreatic Cancer (Unresectable) | 37 | 2021-12-15actual | — | 2023-03-02 |
| Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney DiseaseNCT04059913Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 WeeksRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Roxadustat | CKD Anemia in Dialysis Participants | 318 | 2021-11-19actual | — | 2022-05-06 |
| Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis ParticipantsNCT04484857results2022-07-26Percentage of Participants With Mean Hb Value ≥10 g/dLOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Roxadustat | Anemia Associated With End Stage Renal Disease | 283 | 2021-07-09actual | — | 2022-07-26 |
| Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis ParticipantsNCT04410198results2022-09-13Percentage of Participants With Mean Hb Value ≥10 g/dLOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Roxadustat | Anemia Associated With End Stage Renal Disease (ESRD) | 203 | 2021-06-30actual | — | 2022-09-13 |
| Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced AnemiaNCT04076943results2022-06-03Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) TransfusionOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Roxadustat | Chemotherapy Induced Anemia | 92 | 2021-03-26actual | — | 2022-06-03 |
| Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 DiseaseNCT04432298results2022-07-18Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: The study was terminated by Sponsor due to low enrollment. | Drug: Pamrevlumab, Placebo | COVID-19 | 22 | 2021-03-22actual | — | 2022-07-18 |
| Trial of Pamrevlumab (FG-3019), in Non-Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)NCT02606136results2021-12-30Annual Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) at Week 104Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Sponsor Decision | Drug: Pamrevlumab | Duchenne Muscular Dystrophy | 21 | 2020-05-07actual | — | 2024-08-27 |
| Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney DiseaseNCT01630889results2021-10-01Change From Baseline in Hb Over TimeOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Roxadustat | Chronic Kidney Disease, End Stage Renal Disease, Anemia | 15 | 2019-12-12actual | — | 2021-10-01 |
| A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving DialysisNCT01750190results2021-10-01United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue TherapyRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Roxadustat, Placebo | CKD Anemia | 922 | 2018-09-24actual | — | 2021-10-01 |
| Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis ParticipantsNCT02052310results2021-10-01US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Roxadustat, Epoetin Alfa | Anemia in Incident Dialysis Patients | 1,043 | 2018-09-21actual | — | 2021-10-01 |
| Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable DialysisNCT02273726results2021-10-29US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue TherapyRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Epoetin Alfa, Roxadustat | CKD Anemia in Stable Dialysis Patients | 741 | 2018-09-19actual | — | 2021-10-29 |
| Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)NCT01890265results2020-09-04Change From Baseline in FVC (Percent of Predicted FVC Value [% Predicted]) to Week 48Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan: Part 1 ↗ · Statistical Analysis Plan: Part 2 ↗ | Phase 2 | Completed | Drug: Pamrevlumab, Placebo, Sub-Study: Pirfenidone, Sub-Study: Nintedanib | Idiopathic Pulmonary Fibrosis | 160 | 2017-11-16actual | — | 2020-09-04 |
| FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney DiseaseNCT02652806Hb mean change from baselineRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: FG-4592, Epoetin Alfa | Anemia | 305 | 2017-01-24actual | — | 2017-08-24 |
| FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on DialysisNCT02652819Change in Hb from baseline to the average levelRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: FG-4592, Placebo | Anemia | 154 | 2017-01-24actual | — | 2017-08-24 |
| A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B InfectionNCT01217632To determine the efficacy of FG-3019 administered every 3 weeks for 45 weeks on liver fibrosis in subjects with chronic active hepatitis B infection on entecavir therapyRandomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Study terminated due to an unexpected prominent effect of entecavir alone in this patient population. | Drug: FG-3019, Placebo, Entecavir | Liver Fibrosis Due to Chronic Hepatitis B Infection | 114 | Jun 2015actual | — | 2016-08-16 |
| Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary FibrosisNCT01262001To determine the safety and tolerability of FG-3019 administered at doses of 15 mg/kg (Cohort 1 and Cohort 1-EX) and 30 mg/kg (Cohort 2 and Cohort 2-EX) every 3 wks for 45 weeks, and every 3 weeks thereafter for three additional treatment years.Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: FG-3019, FG-3019 | Idiopathic Pulmonary Fibrosis | 90 | 2014-06-26actual | — | 2019-10-09 |
| A Phase 1 Study of Safety and Bioactivity With FG-3019 in Combination With Gemcitabine and Erlotinib for Subjects With Locally Advanced or Metastatic Pancreatic CancerNCT01181245To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinibNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: FG-3019 | Locally Advanced or Metastatic Pancreatic Cancer | 50 | May 2014actual | — | 2014-08-06 |
| Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in ChinaNCT01596855Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7.Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: FG-4592, Epoetin Alfa | Anemia in End Stage Renal Disease | 96 | Jan 2013actual | — | 2013-02-04 |
| Study of FG-4592 in Subjects With Chronic Kidney Disease in ChinaNCT01599507Maximum change in hemoglobin by Week 9 from baselineRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: FG-4592, Placebo | Anemia in Chronic Kidney Disease | 91 | Jan 2013actual | — | 2014-03-03 |
| Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent TreatmentNCT01414075results2021-10-01Maximum Change From Baseline in Hb During Weeks 3-13Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Roxadustat, Oral Iron, IV Iron | Dialysis, Anemia | 60 | 2013-01-10actual | — | 2021-10-01 |
| Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance HemodialysisNCT01147666results2022-01-11Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks OnlyRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Roxadustat, Epoetin Alfa · Other: Placebo | End Stage Renal Disease, Anemia | 161 | 2012-10-15actual | — | 2022-01-11 |
| Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With AnemiaNCT01244763results2022-02-10Number (%) of Participants With an Hb Response by Week 17Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Roxadustat | Chronic Kidney Disease, Anemia | 145 | 2012-06-13actual | — | 2022-02-10 |
| Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB TherapyNCT00913393Measure: change from baseline in 24-hour urinary ACR for each arm compared with placeboRandomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Study was terminated early for business purposes and as a result of a strategic decision to shift focus to another indication. | Drug: FG-3019, FG-3019, Placebo | Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Kidney Disease | 46 | Jun 2010actual | — | 2019-02-22 |
| Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring DialysisNCT00761657results2021-11-19Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined)Randomized · Single-masked · Treatment | Phase 2 | Completed | Drug: Roxadustat, Placebo | Chronic Kidney Disease, Anemia | 117 | 2010-06-21actual | — | 2021-11-19 |
| Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult SubjectsNCT01376063Change in plasma concentration of RosiglitazoneNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: FG-4592 | Healthy Adult Subjects | 20 | May 2010actual | — | 2011-06-20 |
| Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic NephropathyNCT00754143Safety and tolerability of FG-3019Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: FG-3019, FG-3019, FG-3019 | Diabetes Mellitus, Diabetic Nephropathy | 38 | Dec 2009actual | — | 2019-08-02 |
| Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)NCT00782561Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for MedicationsOpen-label · Treatment | Phase 1 | Terminated | Drug: FG-3019 | Focal Segmental Glomerulosclerosis | 2 | 2009-06-18actual | — | 2019-07-31 |
| Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary FibrosisNCT00074698Number of Participants With Treatment-emergent Adverse Events (TEAEs)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: FG-3019 | Idiopathic Pulmonary Fibrosis | 21 | — | — | 2023-07-12 |
| Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes MellitusNCT00102297SafetyNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: FG-3019 | Diabetes Mellitus | 20 | — | — | 2007-12-12 |
| A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human ErythropoietinNCT00456053Hemoglobin (Hb) responseRandomized · Single-masked · Treatment | Phase 2 | Completed | Drug: FG2216 | Renal Anemia | 145 | — | — | 2007-11-06 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19