Previous clinical observations of potential benefit from Roxadustat in this complex patient population prompted this investigation Therefore, the investigators designed this retrospective, observational study to thoroughly investigate the effects of Roxadustat on heart failure treatment and ventricular remodelling in this specific patient population, aiming to provide new insights for patients management.

Start Date01 Dec 2025

Sponsor / Collaborator

Southeast University Affiliated Zhonda Hospital

NCT07162090

/ Not yet recruitingPhase 4IIT

Observation of the Impact of Hypoxia - Inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients

Sarcopenia, abbreviated as muscle loss, is a prevalent complication among patients with chronic kidney disease (CKD), particularly those with end - stage renal disease (ESRD). It significantly impacts patients' quality of life. The prevalence of sarcopenia in patients receiving maintenance hemodialysis (MHD) ranges from 32.7% to 73.5%, which is substantially higher than that in the general population (5% - 13%). Sarcopenia significantly elevates the mortality risk in MHD patients. Specifically, sarcopenia patients experience an increased all - cause mortality rate, a heightened risk of cardiovascular events, a decline in quality of life, and an augmented risk of falls and fractures. A close pathophysiological relationship exists between the hypoxia - inducible factor - 1 (HIF - 1) pathway and sarcopenia. HIF - 1α serves as a key transcription factor for cells to respond to hypoxic conditions. Under normoxic conditions, HIF - 1α is hydroxylated by prolyl hydroxylase (PHD) and subsequently undergoes ubiquitination - mediated degradation. Conversely, under hypoxic circumstances, HIF - 1α is stably expressed, translocates into the nucleus, and activates downstream target genes. HIF - 1α promotes the expression of genes associated with glycolysis, such as GLUT1 and LDHA, while inhibiting mitochondrial oxidative phosphorylation. This results in a shift of skeletal muscle energy metabolism from aerobic to anaerobic pathways. Research has revealed that the protein level of HIF - 1α is significantly decreased in sarcopenia patients. Roxadustat capsules, an oral medication, represent the world's first small - molecule hypoxia - inducible factor prolyl hydroxylase inhibitor (HIF - PHI) developed for the treatment of renal anemia. The physiological function of HIF - 1α not only enhances the expression of erythropoietin but also upregulates the expression of erythropoietin receptors and proteins involved in promoting iron absorption and circulation. Theoretically, roxadustat has the potential to improve sarcopenia. However, due to its prominent effect on anemia correction, it is currently only clinically applicable to anemic patients. This study aims to use ESA as a control to investigate the effect of roxadustat on sarcopenia in hemodialysis patients during the treatment of renal anemia.

Start Date10 Sep 2025

Sponsor / Collaborator

Tianjin Medical University General Hospital

ChiCTR2500106730

/ Not yet recruitingPhase 4IIT

Observation of the Impact of Hypoxia - Inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients

Start Date01 Aug 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

100 Clinical Results associated with Roxadustat

100 Translational Medicine associated with Roxadustat

100 Patents (Medical) associated with Roxadustat

578

Literatures (Medical) associated with Roxadustat

31 Dec 2026·RENAL FAILURE

Efficacy and safety of prolyl hydroxylase inhibitors for anemia in chronic kidney disease: a network meta-analysis

Review

Author: Li, Yongmei ; Zhan, Yaoxuan ; Niu, Yuanchen ; Fang, Yi ; Xu, Haimei ; Hu, Zhiqin ; Wang, Tenghua ; Li, Chen ; He, Jin

This Bayesian network meta-analysis evaluated the efficacy and safety of six prolyl hydroxylase inhibitors (PHIs) versus erythropoiesis-stimulating agents (ESAs) or placebo for chronic kidney disease (CKD) anemia. Electronic databases were searched through 1 May 2025. The prespecified primary outcome was change in hemoglobin, while secondary outcomes included iron metabolism indices (serum iron, transferrin saturation [TSAT], ferritin, hepcidin) and overall composite adverse events (AEs). Surface under the cumulative ranking curve (SUCRA) was used for ranking. Forty-six randomized controlled trials with 32,305 patients were included. In non-dialysis CKD (ND-CKD), roxadustat yielded the greatest hemoglobin rise (MD = 1.21 g/dL, 95% CI: 0.72-1.71; SUCRA = 88.6%) versus placebo and ESA. In dialysis CKD (D-CKD), roxadustat again ranked the highest (MD = 1.78 g/dL, 95% CI: 1.32-2.24; SUCRA = 86.2%) versus ESA and other PHIs. For TSAT, ESA ranked best in ND-CKD (MD = 5.24%, 95% CI: 1.16-9.32), while daprodustat led in D-CKD (MD = 3.07%, 95% CI: 0.22-5.91). Roxadustat improved serum iron in D-CKD (MD = 6.19 μg/dL, 95% CI: 2.81-9.58), and vadadustat and roxadustat reduced hepcidin in ND-CKD. Consistency assessment revealed no statistically significant heterogeneity/inconsistency between direct/indirect comparisons, supporting the robustness of the results. Regarding safety, ESA had the lowest AE risk in ND-CKD (OR = 0.85, 95% CI: 0.74-0.98), while roxadustat ranked lowest (SUCRA = 18.4%). Roxadustat demonstrated the strongest efficacy in hemoglobin improvement but higher AE incidence in ND-CKD, whereas ESA and daprodustat showed safety and iron metabolism benefits, supporting individualized therapy for renal anemia.Registration number: PROSPERO (CRD420251066181).

01 Mar 2026·CELLULAR SIGNALLING

Roxadustat induces erythroid differentiation of erythroleukemia cells through the hypoxia inducible factor-α/GATA binding protein 1 axis

Article

Author: Chen, Yuanzhong ; Lin, Jia ; Luo, Zhehan ; Wu, Yong ; Yang, Liqing ; Wang, Shuang

BACKGROUND:

Acute erythroleukemia (AEL) is a rare type of acute myeloid leukemia characterized by severe anemia. Roxadustat is a marketed first-generation hypoxia inducible factor-proline hydroxylase inhibitor (HIF-PHI), currently widely used in anemia associated with chronic kidney disease. Studies on roxadustat in anemia related to myeloid neoplasms remains limited.

METHODS:

Erythroid differentiation levels of HEL and K562 cells after roxadustat treatment were assessed via flow cytometry and benzidine staining. Real timequantitative PCR and western blot were performed to detect mRNA and protein expression levels of erythroid differentiation-related genes. Small interfering RNA (siRNA) was used to knock down HIF-1α or HIF-2α to elucidate the primary target of roxadustat-induced erythropoiesis. To study the role of GATA binding protein 1 (GATA1) in roxadustat-induced erythropoiesis, CRISPR/Cas9-mediated GATA1 knockout cell lines were established. Chromatin immunoprecipitation-PCR and dualluciferase reporter assay were conducted to determine the interaction between HIF-α and GATA1.

RESULTS:

Roxadustat significantly promoted erythroid differentiation in HEL and K562 cells. Knockdown of HIF-2α rather than HIF-1α, and knockout of GATA1 both effectively inhibited this effect. Both HIF-1α and HIF-2α are responsible for the direct upregulation of GATA1 expression under hypoxia, with HIF-1α as the dominant transcription factor. Despite potentially different roles of HIF-1α and HIF-2α in leukemogenesis, roxadustat combined with ruxolitinib or imatinib exhibited synergistic anti-leukemia effect in HEL and K562 cells, respectively.

CONCLUSIONS:

Roxadustat induces erythropoiesis in erythroleukemia cells primarily by targeting HIF-2α and was partially GATA1-dependent. Besides upregulating erythropoietin, our study revealed the HIF-α/GATA1 axis as another critical regulatory mechanism for hypoxia-driven erythropoiesis.

01 Feb 2026·CANCER LETTERS

Lactic acid promotes an MDSC-like phenotype via HIF1α stabilization with impact on prognosis in renal cell carcinoma

Article

Author: Strieder, Nicholas ; Sala-Hojman, Ada ; Kreutz, Marina ; Ferretti, Roberta ; Afonso, Julieta ; Heinrich, Timo ; Herr, Wolfgang ; Hofbauer, Joshua ; Hau, Peter ; Althammer, Michael ; Martowicz, Agnieszka ; Babl, Nathalie ; Maddaloni, Marianna ; Herhaus, Christian ; Rehli, Michael ; Schmidl, Christian ; Friedl, Sarah ; Simon, Malte ; Brummer, Christina ; Mayr, Roman ; Laufs, Johanna ; Bruss, Christina ; Matos, Carina ; Siska, Peter J ; Loipfinger, Stefan ; Renner, Kathrin ; Singh, Sukh M ; Decking, Sonja-Maria ; Gebhard, Claudia ; Oefner, Peter J ; Baltazar, Fatima ; Voll, Florian ; Hoffmann, Petra ; Schnell, Annette ; Vollmann-Zwerenz, Arabel ; Evert, Katja ; Dettmer, Katja

Paradoxically, immune cell infiltration correlates with worse prognosis in renal cell carcinoma (RCC) patients, with tumor-associated myeloid cells playing a key role in tumor progression. However, little is known about factors driving their polarization. Here, we investigated the link between RCC-related glycolysis, hypoxia-inducible factor (HIF)1α-associated myeloid inflammation, and patient prognosis. TCGA data revealed a strong correlation between the expression of monocarboxylate transporter 4 (MCT4), the myeloid marker CD14 and patient survival in ccRCC patients. scRNAseq data confirmed high MCT4 expression in both tumor and myeloid cells, suggesting lactate transport. In vitro analyses proved lactate uptake by CD14⁺ monocytes, which stabilized HIF1α and induced an MDSC-like, HLA-DR low phenotype. In line, the HIF1α-stabilizing drug Roxadustat increased the number of CD14⁺ HLA-DR low cells. Lactate uptake also increased protein lactylation. To further investigate the interplay between RCC tumor and myeloid cells, we established a 3D spheroid co-culture model and analyzed the effects of MCT inhibitors. This 3D model reflected tumor-myeloid cell interactions, as spheroid-infiltrating myeloid cells exhibited spontaneous IL-6 secretion comparable to patient-derived RCC cultures. Inhibition of lactate secretion reduced lactate and IL-6 secretion while increasing CD14⁺ HLA-DR⁺ cells. These findings were validated in patient-derived RCC cultures treated with anti-glycolytic drugs. Our data dissect the intratumoral network of RCC and show that tumor-derived lactate promotes a pro-tumorigenic myeloid phenotype with low MHC-II but high immune-checkpoint, LOX-1 and S100A8/9 expression. Blocking MCT disrupts this interplay, offering a promising strategy to re-educate tumor-associated myeloid cells and enhance tumor immune surveillance.

195

News (Medical) associated with Roxadustat

07 Jan 2026

·fibrogen.gcs-web.com

FibroGen Rebrands as Kyntra Bio to Reflect a New Era of Focus and Momentum

Name change to Kyntra Bio reflects the newly sharpened focus of the Company on novel therapies with potential for outsized impact in oncology and rare disease Kyntra Bio will begin trading on Nasdaq under the trading symbol “KYNB” effective January 8th SAN FRANCISCO, Jan. 07, 2026 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN), today announced it is rebranding the company to Kyntra Bio, representing the next step of the transformation of the Company and its focus on oncology and rare disease assets. The Company’s common stock will begin trading under the new Nasdaq symbol “KYNB” at stock market open on January 8, 2026. “2025 was a transformational year, highlighted by the sale of FibroGen China, the payoff of our senior secured term loan, and the extension of our cash runway into 2028. We begin this year as Kyntra Bio, a name that captures our company journey and evolution and reflects our purposeful move to a company obsessed with creating outsized impact for patients and shareholders,” said Thane Wettig, Chief Executive Officer of Kyntra Bio. “Today, with a sharpened direction, Kyntra Bio is laser-focused on our mid- and late-stage assets – specifically, FG-3246, our first-in-class, CD46 targeting antibody drug conjugate, and FG-3180, our companion PET imaging agent, currently in a Phase 2 monotherapy trial in prostate cancer, and roxadustat, our Phase 3 ready asset, for which we recently received Orphan Drug Designation in myelodysplastic syndromes. We are thrilled to move forward with renewed purpose into this bold era for our company and are excited for what is in front of us.” Recent Highlights and Upcoming Milestones FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent) Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC are expected to be presented at ASCO GU in the first quarter of 2026. Interim results from the recently commenced Phase 2 monotherapy trial are expected in the second half of 2026. The trial will also assess the diagnostic performance of FG-3180 to determine the potential correlation between CD46 expression and response to FG-3246. Roxadustat Granted Orphan Drug Designation from the FDA for the treatment of myelodysplastic syndromes (MDS). Submitted the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS and high transfusion burden to the U.S. Food and Drug Administration. In addition to the new name, the Company is refreshing its corporate website to better reflect the Company’s strategy moving forward. The CUSIP number for the Company’s common stock is not affected by the name change. About Kyntra Bio Kyntra Bio is a biopharmaceutical company focused on development of novel therapies in oncology and rare disease. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.kyntrabio.com. Forward-Looking Statements This release contains forward-looking statements regarding Kyntra Bio’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of Kyntra Bio products and product candidates, statements under the caption “Recent Highlights and Upcoming Milestones”, statements about regulatory interactions, the payoff of the Morgan Stanley Tactical Value term loan, statements regarding cash, such as the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund Kyntra Bio’s operating plans into 2028, and statements about Kyntra Bio’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Kyntra Bio’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in Kyntra Bio’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Kyntra Bio undertakes no obligation to update any forward-looking statement in this press release, except as required by law. For Investor Inquiries: David DeLucia, CFA Senior Vice President and Chief Financial Officer ir@kyntrabio.com Source: FibroGen, Inc.

Orphan DrugPhase 2Drug ApprovalPhase 3ADC

15 Dec 2025

·fibrogen.gcs-web.com

Roxadustat Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes by the U.S. Food and Drug Administration

Company is on track to file the Phase 3 protocol in the fourth quarter of 2025 SAN FRANCISCO, Dec. 15, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS). “The Orphan Drug Designation granted to roxadustat for MDS underscores the significant treatment gap in this indication, and highlights patients’ need for additional convenient treatments that can provide durable response,” said Thane Wettig, Chief Executive Officer of FibroGen. “Roxadustat showed an improvement in transfusion-independence in a subset of patients with high transfusion burden in a post-hoc analysis from the Phase 3 MATTHERHORN trial, which along with its favorable tolerability profile and oral route of administration has the ability to set it apart from current second-line treatments. Our team is finalizing the Phase 3 protocol in this patient population for submission to the FDA in the fourth quarter of 2025.” There are approximately 58,000 patients diagnosed with LR-MDS in the U.S. with 85% of them suffering from anemia. Anemia in patients with MDS is associated with increased risk of cardiovascular complications and the need for blood transfusions. Transfusion-dependent patients suffer higher rates of complications and decreased quality of life. Current first-line treatments lead to transfusion independence in less than 50% of patients and relief is often temporary with limited options for second line and beyond treatments. In a post-hoc analysis from the Phase 3 MATTERHORN trial, roxadustat demonstrated transfusion independence benefits compared to placebo in patients with high transfusion burden. The FDA Orphan Drug Designation is granted to drugs intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Benefits of the designation may include exemption from certain FDA fees, financial incentives for qualified clinical development, and seven years of market exclusivity in the U.S. following drug approval. About Myelodysplastic Syndromes Anemia Myelodysplastic syndromes (MDS) are a group of disorders characterized by dysfunctional progenitor blood cells and stem cells, resulting in chronic anemia in most patients. Annual incidence rates of MDS are estimated to be 4.9/100,000 adults in the U.S, of which 77% are considered lower-risk MDS. Approximately 80% of patients with MDS have anemia at the time of diagnosis, and around 60% of patients with MDS will experience severe anemia (hemoglobin <8 g/dL) at some point during the course of their disease. Anemia in patients with MDS is associated with increased risk of cardiovascular complications and the need for blood transfusion. Approximately 50% of patients with MDS require regular red blood cell transfusions. Transfusion-dependent MDS patients suffer higher rates of cardiac events, infections, and iron overload with the related complications. In addition, anemia frequently leads to significant fatigue, cognitive dysfunction, and decreased quality of life. Today, patients are routinely treated with erythropoiesis-stimulating agents (ESAs), luspatercept, imetelstat, or lenalidomide in lower-risk MDS with isolated del(5q), and hypomethylating agents (HMAs) in higher-risk disease. Only 35-40% of patients respond to current treatments and the durability of response is short. Moreover, these treatments are challenging to dose-calibrate and can only be administered via subcutaneous injection or through IV infusion. There remains a high unmet need for the treatment of anemia associated with MDS, and new strategies that provide durable response and the convenience of oral administration are highly desired in managing patients with MDS. About Roxadustat Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is approved in Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.fibrogen.com. Forward-Looking Statements This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of it and its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, convenience, and potential clinical or commercial success of FibroGen products and product candidates, statements about regulatory interactions, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law. For Investor Inquiries: David DeLucia, CFA Senior Vice President and Chief Financial Officer ir@fibrogen.com Source: FibroGen, Inc.

Phase 2Phase 3Orphan DrugDrug ApprovalClinical Result

10 Nov 2025

·fibrogen.gcs-web.com

FibroGen Reports Third Quarter 2025 Financial Results and Provides Business Update

Completed the sale of FibroGen China to AstraZeneca for approximately $220 million Initiated the Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC) Reached agreement with the U.S. Food and Drug Administration (FDA) on important design elements for the pivotal Phase 3 trial for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell (RBC) transfusion burden Final protocol submission anticipated in 4Q 2025 Topline results from the investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC expected to be presented at a medical conference in 1Q 2026 Cash, cash equivalents, investments, and accounts receivable of $121.1 million , providing cash runway into 2028 FibroGen to host conference call and webcast presentation today at 5:00 PM ET Final protocol submission anticipated in 4Q 2025 SAN FRANCISCO , Nov. 10, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the third quarter 2025 and provided an update on the company’s recent developments. “With the completion of the transformative sale of our FibroGen China operations, we have significantly simplified our capital structure and extended our cash runway into 2028. Notably, we initiated the Phase 2 monotherapy trial of FG-3246 and its companion diagnostic FG-3180, with an interim analysis anticipated in the second half of 2026,” said Thane Wettig , Chief Executive Officer, FibroGen . “We remain on track to submit the Phase 3 protocol for roxadustat in LR-MDS in the fourth quarter of 2025 and continue to assess its development options. We are excited to continue building on the strong momentum we have gained throughout this year.” Recent Developments and Key Highlights of Third Quarter 2025: Completed the sale of FibroGen China to AstraZeneca for a total consideration of approximately $220 million , consisting of $85 million in enterprise value and approximately $135 million in net cash held in China . Successfully repaid term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China , South Korea , and those licensed to Astellas. Initiated the Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC. The trial will also evaluate FG-3180 as a companion PET imaging agent and a potential predictive patient selection biomarker. Reached agreement with the FDA on important design elements for the pivotal Phase 3 trial for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden. FibroGen continues to assess both internal development or partnership opportunities for this program. Successfully repaid term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China , South Korea , and those licensed to Astellas. Upcoming Milestones: FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent) Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC are expected to be presented at a medical conference in the first quarter of 2026. Interim results from the Phase 2 monotherapy trial are expected in the second half of 2026. The trial will also assess the diagnostic performance of FG-3180 to determine the potential correlation between CD46 expression and response to FG-3246. Roxadustat FibroGen remains on track to file the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden in the fourth quarter of 2025. Financial: Total revenue from continuing operations for the third quarter of 2025 was $1.1 million , as compared to $0.1 million for the third quarter of 2024. Net loss from continuing operations for the third quarter of 2025 was $13.1 million , or $3.25 loss per basic and diluted share, compared to a loss of $48.3 million , or $12.01 loss per basic and diluted share, one year ago. On September 30, 2025 , FibroGen reported cash, cash equivalents, accounts receivable, and investments of $121.1 million . The Company expects its cash, cash equivalents, accounts receivable, and investments to be sufficient to fund operating plans into 2028. Conference Call and Webcast PresentationThe FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website. About FG-3246FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide. An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The Phase 2 monotherapy dose optimization trial for FG-3246 in metastatic castration-resistant prostate cancer has been initiated. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority. About RoxadustatRoxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is approved in China , Europe , Japan , and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States , Canada , Mexico , and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan , Europe , Turkey , Russia , and the Commonwealth of Independent States, the Middle East , and South Africa . About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China , Europe , Japan , and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.fibrogen.com. Forward-Looking Statements This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, convenience, and potential clinical or commercial success of FibroGen products and product candidates, statements under the caption “Upcoming Milestones”, statements about regulatory interactions, the estimated net cash portion of the purchase price of the sale of FibroGen China, statements regarding cash, such as the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund FibroGen’s operating plans into 2028, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law. (1) The condensed consolidated balance sheet amounts at December 31, 2024 are derived from audited financial statements. For Investor Inquiries: David DeLucia , CFASenior Vice President and Chief Financial Officerir@fibrogen.com Source: FibroGen, Inc.

Phase 2Phase 1Drug ApprovalPhase 3Clinical Result

100 Deals associated with Roxadustat

External Link

KEGG	Wiki	ATC	Drug Bank
D10593	Roxadustat	B03XA05	DB04847

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Anemia	United Kingdom	Astellas Pharma, Inc.	01 Dec 2021
Anemia in chronic kidney disease	South Korea	AstraZeneca PLC	09 Jul 2021
Anemia of renal disease	Japan	Astellas Pharma, Inc.	20 Sep 2019
chronic renal failure anemia	China	FibroGen (China) Medical Technology Development Co. Ltd.	17 Dec 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 3	China	Kyntra Bio, Inc.	16 Mar 2022
Myelodysplastic Syndromes	Phase 3	United States	AstraZeneca PLC	29 Jan 2018
Myelodysplastic Syndromes	Phase 3	United States	Astellas Pharma, Inc.	29 Jan 2018
Myelodysplastic Syndromes	Phase 3	United States	Kyntra Bio, Inc.	29 Jan 2018
Myelodysplastic Syndromes	Phase 3	Australia	AstraZeneca PLC	29 Jan 2018
Myelodysplastic Syndromes	Phase 3	Australia	Kyntra Bio, Inc.	29 Jan 2018
Myelodysplastic Syndromes	Phase 3	Australia	Astellas Pharma, Inc.	29 Jan 2018
Myelodysplastic Syndromes	Phase 3	Belgium	Astellas Pharma, Inc.	29 Jan 2018
Myelodysplastic Syndromes	Phase 3	Belgium	Kyntra Bio, Inc.	29 Jan 2018
Myelodysplastic Syndromes	Phase 3	Belgium	AstraZeneca PLC	29 Jan 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2100044799 (NANLING, ASN2025)	Phase 4	Anemia	195	Roxadustat	jnjfbszocf(nexshslehe) = decreased from baseline (-81.2 μg/L [95%CI -112.9 to -49.6]) oghrxxleck (kfmpoflaqk ) View more	Positive	07 Nov 2025
NCT04408820 (Pubmed \| Expert Opin Pharmacother)	Not Applicable	Anemia in chronic kidney disease C-reactive protein \| albumin	2,084	roxadustat (Non-dialysis-dependent group)	klscrjpjwx(suvaljsamd) = jrcqhsycjx kzsqjsdvsl (yubpwnuyuv ) View more	Positive	04 Mar 2025
				roxadustat (Hemodialysis group)	klscrjpjwx(suvaljsamd) = xsqjnvqrom kzsqjsdvsl (yubpwnuyuv ) View more
NCT05301517 (Pubmed \| J Clin Oncol)	Phase 3	Anemia	159	Roxadustat	niyracjkar(ozbrfcyist) = kutvebjvfm aczypofmzr (drjpphghla, 13.58 - 20.71)	Positive	10 Jan 2025
				Recombinant human erythropoietin-α (rHuEPO-α)	niyracjkar(ozbrfcyist) = myhysklfrq aczypofmzr (drjpphghla, 11.34 - 19.50)
NCT04059913 (ASN2024)	Phase 4	-	178	Roxadustat QW	evxtmvgrcj(dcraatvmez) = ziytnjbvbv xxxwallrma (vjjubclwki, 103.6 - 108.9) View more	Non-inferior	24 Oct 2024
				Roxadustat BIW	evxtmvgrcj(dcraatvmez) = rkmchvdkiu xxxwallrma (vjjubclwki, 104.4 - 109.7) View more
NCT04059913 (ASN2024)	Phase 4	Anemia in chronic kidney disease	178	Roxadustat QW	frjewovqxj(zhybpymtzv) = ocpphplhmf hghjqpqhub (rgjrourjkh )	-	24 Oct 2024
				Roxadustat BIW	frjewovqxj(zhybpymtzv) = jxlaapdjil hghjqpqhub (rgjrourjkh )
NCT03263091 (MATTERHORN, CTgov)	Phase 3	Anemia \| Myelodysplastic Syndromes	184	Roxadustat (OL Component (Cohort 1): Roxadustat 1.5 mg/kg)	qtlcimoqyt = wqfghsshtw mrejeczrhr (tpoojpouzh, sqgkpxsxwn - jyashgsvew) View more	-	01 Aug 2024
				Roxadustat (OL Component (Cohort 2): Roxadustat 2.0 mg/kg)	qtlcimoqyt = ezserzkcsc mrejeczrhr (tpoojpouzh, rglonpyzaq - dugskpfqur) View more
NCT04655027 (CTgov)	Phase 4	Anemia in chronic kidney disease	25	Roxadustat (Roxadustat)	rddebulmec(nvnbrimhty) = ntcecqbqrr nwugqnfjwp (pplubnnkct, 28.1506) View more	-	22 Apr 2024
				rHuEPO (rHuEPO)	rddebulmec(nvnbrimhty) = gfqyqncsyh nwugqnfjwp (pplubnnkct, 9.7369) View more
NCT02052310 \| NCT02174731 \| NCT02278341 \| NCT02273726 (Pubmed)	Phase 3	Chronic Kidney Diseases hemoglobin level \| transferrin saturation	2,354	Roxadustat	igxduwtqpw(bcyqguduaz) = high hemoglobin rate of rise (≥ 0.5 g/dL/week; odds ratio [OR] 2.09; 95% confidence interval [CI] 0.98-4.46) showed a trend towards increased risk of thromboembolic events before week 12 cdngwfjndx (mnazdpuhte ) View more	-	01 Apr 2024
NCT02780141 \| NCT02952092 \| NCT02779764 \| NCT02780726 (Pubmed \| Adv Ther)	Phase 3	Chronic Kidney Diseases transferrin saturation \| transferrin level \| roxadustat dose ... View more	444	Roxadustat	udzwkojbtc(ducwcqdqyi) = nvooktbdio yqwdztycdj (cijnjnysip )	Negative	01 Apr 2024
NCT03263091 (MATTERHORN, GlobeNewswire) Manual	Phase 3	Myelodysplastic Syndromes	62	Roxadustat (higher transfusion burden)	ppppngdech(ihxhrhbaki) = vlkxdjzhib hlabpbcmlf (inbqvmvqvr, 20.8 - 53.8) View more	Positive	09 Dec 2023
				placebo (higher transfusion burden)	ppppngdech(ihxhrhbaki) = kgzyijoyqk hlabpbcmlf (inbqvmvqvr, 2.4 - 30.2) View more

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