A Phase 3, Open-label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics of Roxadustat for the Treatment of Anemia in Pediatric Participants with Chronic Kidney Disease - -

Start Date01 Jun 2024

Sponsor / Collaborator

Astellas BV

ACTRN12624000188538 / Not yet recruitingPhase 2

Hypoxic Enhancement Before Major Surgery (HYPE): A pilot randomised controlled trial of preoperative Roxadustat vs placebo in patients undergoing major surgery, assessing safety, effectiveness and feasibility.

Start Date15 Apr 2024

Sponsor / Collaborator-

CTR20240386 / CompletedNot Applicable

罗沙司他胶囊单中心、随机、开放、单剂量、两制剂、两周期、两序列交叉设计，空腹和餐后状态下的人体生物等效性研究。

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design, bioequivalence study of rosuvastatin capsules in humans under fasting and fed conditions.

本试验旨在研究单次空腹和餐后口服安徽省先锋制药有限公司研制、生产的罗沙司他胶囊（50 mg）的药代动力学特征；以珐博进（中国）医药技术开发有限公司生产的罗沙司他胶囊（爱瑞卓®，50 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to study the pharmacokinetic characteristics of rosuvastatin capsules (50 mg) developed and produced by Anhui Pioneer Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using rosuvastatin capsules (Aeridro®, 50 mg) produced by FibroGen (China) Pharmaceutical Technology Development Co., Ltd. as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.

Start Date29 Feb 2024

Sponsor / Collaborator

Anhui Pioneer Pharmaceutical Co. Ltd.

100 Clinical Results associated with Roxadustat

100 Translational Medicine associated with Roxadustat

100 Patents (Medical) associated with Roxadustat

369

Literatures (Medical) associated with Roxadustat

01 Mar 2024·Journal of hypertension

Hypoxia-inducible factor-prolyl hydroxylase inhibitor Roxadustat (FG-4592) reduces renal fibrosis in Dahl salt-sensitive rats

Article

Author: Naito, Yoshiro ; Masuyama, Tohru ; Yasumura, Seiki ; Tsujino, Takeshi ; Okuno, Keisuke ; Ishihara, Masaharu ; Asakura, Masanori

Objective::

Although hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitors have been developed for the treatment of renal anemia, their effects on cardiac and renal dysfunction remain unknown. We previously reported on Dahl salt-sensitive rats, in a rat model of salt-sensitive hypertension, that exhibited anemia and impaired expression of duodenal iron transporters after the development of hypertensive cardiac and renal dysfunction. Therefore, we investigated the effects of Roxadustat (FG-4592), an HIF-PH inhibitor, on anemia, iron regulation, and cardiac and renal dysfunction in Dahl salt-sensitive rats.

Methods::

Six-week-old male Dahl salt-sensitive rats were fed a normal or high-salt diet for 8 weeks. A further subset of Dahl salt-sensitive rats, that were fed a high-salt diet, was administered Roxadustat for 8 weeks.

Results::

Dahl salt-sensitive rats fed a high-salt diet developed hypertension, cardiac and renal dysfunction, and anemia after 8 weeks of feeding. Roxadustat increased hemoglobin and serum erythropoietin levels in Dahl salt-sensitive rats fed a high-salt diet. With regard to the iron-regulating system, Roxadustat lowered hepatic hepcidin gene expression and increased the gene expression of duodenal iron transporters, such as cytochrome b and divalent metal transporter 1, in Dahl salt-sensitive rats fed a high-salt diet. Roxadustat did not affect the development of hypertension and cardiac hypertrophy in Dahl salt-sensitive rats with a high-salt diet; however, Roxadustat treatment attenuated renal fibrosis in these rats.

Conclusions::

Roxadustat ameliorated anemia with affecting the gene expression of the iron-regulating system, and did not affect cardiac hypertrophy but attenuated renal fibrosis in Dahl salt-sensitive rats fed a high-salt diet.

International urology and nephrology

A clinical study on roxadustat for anemia in diabetic nephropathy: a 8-week study

Article

Author: Sun, Dong ; Raj, Ashok ; Xu, Yizhou ; Zheng, Zhifang ; Jia, Ruoyu ; Jiang, Luhua ; Zhang, Xuejie

PURPOSE:

The development of roxadustat is a standard treatment for renal anemia, and multiple clinical trials have proved its safety and efficacy. However, less information is available from trials of the population with diabetic nephropathy (DN). This study aimed to determine whether roxadustat is effective for treating DN.

METHODS:

This was a single-center, retrospective, institutional review board-approved cohort study. The patients with DN were chosen and given roxadustat or erythropoietin (EPO) for 8 weeks. The mean hemoglobin (Hb) level after 8 weeks of treatment served as the primary outcome. Alterations in the iron index and lipid levels were considered secondary objectives. Sub-group analysis was performed to observe the impact of inflammation and glycemic status on Hb.

RESULTS:

A total of 80 patients were enrolled, 40 in each group. After 8 weeks of treatment, the Hb levels in the roxadustat group were higher than those in the control group. The number of patients who achieved Hb response was higher in the roxadustat group than in the control group (77.5% versus 27.5%; P < 0.001). In addition to lowering total cholesterol and low-density lipoprotein cholesterol, roxadustat decreased ferritin and elevated total iron-binding capacity. Compared to the control group, roxadustat was more beneficial for patients with an inflammatory condition and poor glycemic control.

CONCLUSIONS:

Roxadustat treatment remarkably corrected anemia in patients with DN, and its effectiveness was unaffected by inflammation or glycemic control levels. In addition, roxadustat can also reduce a patient's blood lipid level and enhance the body's use of iron.

CLINICAL TRIAL REGISTRATION:

ChiCTR2200057232.

01 Mar 2024·Pediatric nephrology (Berlin, Germany)

Compassionate use of roxadustat for treatment of refractory renal anemia in an infant

Article

Author: Liu, Dengli ; Chen, Yan ; Bai, Haitao ; He, Bizi ; Yang, Yang ; Yang, Yan

Abstract:

Background:

Erythropoiesis-stimulating agents (ESAs) have played an important role in the treatment of renal anemia in children, but cannot improve hemoglobin to target level in some cases. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, can stimulate endogenous erythropoietin production and regulate iron metabolism even in patients with kidney failure. However, roxadustat has not yet been approved for use in children.

Case–diagnosis/Treatment:

We report a case of refractory renal anemia in an 80-day-old boy, who was hyporesponsive to ESAs even in combination with iron supplementation and transfusion. Compassionate use of roxadustat successfully corrected the intractable anemia. Hyperkalemia is a manageable adverse event of concern during follow-up.

Conclusion:

The successful experience in this case may inform the clinical utility of roxadustat for refractory renal anemia in children, which should be further confirmed by well-designed prospective clinical trials.

129

News (Medical) associated with Roxadustat

18 Jun 2024

·www.globenewswire.com

FibroGen to Host Part II of Virtual KOL Investor Event Series to Review FG-3246 Development Program in Metastatic Castration-Resistant Prostate Cancer on June 26, 2024

SAN FRANCISCO, June 18, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced it will host the second part of its virtual KOL investor event series on Wednesday, June 26, 2024 at 10:00 AM ET. To register, click here. The event will feature Rahul Aggarwal, M.D. (University of California San Francisco), who will discuss the unmet need and evolving treatment landscape for prostate cancer, as well as the clinical development program for FG-3246* (also known as FOR46), a CD46 targeting antibody-drug conjugate (ADC) with first-in-class potential for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The initiation of a Phase 2 monotherapy trial in mCRPC is expected in the second half of 2024. The event will additionally review data from the Phase 1b/2 study evaluating FG-3246 in combination with enzalutamide in mCRPC presented at the 2024 American Society of Clinical Oncology (ASCO) meeting. A live question and answer session will follow the formal presentation. This series is intended for investor audiences only. About Rahul Aggarwal, MDRahul Aggarwal, MD is a Professor of Medicine and Thomas Perkins Distinguished Professor of Cancer Research at the University of California San Francisco. He is the Associate Director for Clinical Research in the UCSF Helen Diller Family Comprehensive Cancer Center and the Program Leader for the Genitourinary Oncology program. He specializes in translational and clinical research in prostate cancer, with a particular emphasis on the development of novel therapeutic and imaging modalities for men with advanced prostate cancer. He has led numerous phase 1, 2, and 3 clinical trials in prostate cancer across a number of treatment modalities including small molecule targeted therapies, radioligand therapies, antibody-drug conjugates, and bi-specific T cell engagers. 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 initiation of the Phase 2 monotherapy trial in metastatic castration-resistant prostate cancer is anticipated in the second half of 2024. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, a fully human anti-CTGF monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). 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. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com. Forward-Looking StatementsThis release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its clinical programs for FG-3246. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential success of FibroGen product candidates, and statements about FibroGen’s plans and objectives and typically are 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 quarterly and annual reports on Form 10-Q and Form 10-K, respectively, 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. *FG-3246 is an investigational drug and not approved for marketing by any regulatory authority. For Investor Inquiries:David DeLucia, CFAVice President, Head of Investor Relations and Corporate FP&Air@fibrogen.com For Media Inquiries:Simon MillerVice President, Marketing and Corporate Communicationsmedia@fibrogen.com

ASCOADCDrug Approval

04 Jun 2024

·www.globenewswire.com

FibroGen Announces FDA Clearance of Investigational New Drug Application for FG-3165, a Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors

The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors Plan to begin enrollment in 2H 2024 June 03, 2024 -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. “The FDA’s IND clearance is an important achievement for us, and we are pleased to advance another product from our promising oncology pipeline into the clinic,” said Thane Wettig, Chief Executive Officer of FibroGen. “To date, FG-3165 has demonstrated anti-tumor activity with improved survival in combination with other immune modulatory therapies in mouse cancer models and has shown excellent tolerability in nonclinical safety studies. We are excited to begin enrollment in a Phase 1 trial in the second half of this year and explore the potential of FG-3165 in enhancing anti-tumor immune responses in the tumor microenvironment.” The FDA IND clearance enables FibroGen to initiate a Phase 1 clinical trial evaluating the safety and efficacy of FG-3165 in patients with select solid tumors. The trial is anticipated to begin enrollment in the second half of 2024. FG-3165 is a galectin-9 (“Gal9”) targeted antibody under development for treatment of solid tumors and potentially hematologic malignancies characterized by high Gal9 levels of expression. Gal9 has been reported to signal through multiple immune checkpoints on lymphocytes, including TIM3, VISTA, and PD-1, suppressing T and natural killer cell activation. FG-3165 selectively binds to Gal9 with high affinity and inhibits its ability to induce lymphocyte cell death, resulting in enhanced tumor cell killing. Toxicology material as well as GMP material for the upcoming Phase 1 clinical trial was manufactured in partnership with Just-Evotec Biologics. FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, a fully human anti-CTGF monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (爱瑞卓®, EVRENZOTM) 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. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com. The content above comes from the network. if any infringement, please contact us to modify.

INDImmunotherapyDrug ApprovalPhase 1ADC

03 Jun 2024

·www.globenewswire.com

FibroGen Announces Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate FibroGen’s Immuno-Oncology Assets, FG-3165 (anti-Galectin 9) and FG-3175 (anti-CCR8), in Combination with LIBTAYO® in Upcoming Clinical Trials

FibroGen to evaluate FG-3165, an anti-galectin 9 (Gal9) monoclonal antibody (mAb), as monotherapy treatment as well as in combination with LIBTAYO® in patients with select solid tumorsFibroGen to evaluate FG-3175, an anti-c-c motif chemokine receptor 8 (CCR8) mAb, as monotherapy treatment as well as in combination with LIBTAYO® in patients with select solid tumorsBoth FG-3165 and FG-3175 have demonstrated complementary mechanisms of action with PD-1 inhibitors in preclinical studies SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate FibroGen’s immuno-oncology assets, FG-3165 and FG-3175, in combination with Regeneron’s anti-PD-1 therapy, LIBTAYO® (cemiplimab), in patients with solid tumors. “We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen. “We believe that the mechanisms of action for both FG-3165 (anti-Gal9) and FG-3175 (anti-CCR8) have the potential to be synergistic with cemiplimab, providing the possibility for an improvement in clinical outcomes for patients. We look forward to building a collaborative relationship with Regeneron, who is a leader in oncology therapeutic products development and commercialization.” FG-3165 targets Gal9, which binds multiple immune checkpoints on lymphocytes that suppress T and natural killer (NK) cell activation. FG-3175 targets CCR8, a receptor frequently over-expressed on T regulatory cells in solid tumors. Both FG-3165 and FG-3175 have demonstrated complementary mechanisms of action with PD-1 inhibitors preclinically, and the Company believes that combining LIBTAYO® with either FG-3165 or FG-3175 may result in added clinical benefit for patients. Under the clinical study collaboration and supply agreement, Regeneron will provide drug supply to FibroGen, who will be the sponsor of each Phase 1 monotherapy and combination trial. Each company retains all rights to their respective compounds, including as a monotherapy or as combination therapies. Earlier today, FibroGen separately announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for FG-3165 in patients with solid tumors. An IND submission for FG-3175 is anticipated in 2025. About FG-3165FG-3165 is a galectin-9 (Gal9) targeted antibody under development for treatment of solid tumors and potentially hematologic malignancies characterized by high Gal9 levels of expression. Gal9 has been reported to signal through multiple immune checkpoints on lymphocytes, including TIM3, VISTA, and PD-1, suppressing T and natural killer cell activation. FG-3165 selectively binds to Gal9 with high affinity and inhibits its ability to induce lymphocyte cell death, resulting in enhanced tumor cell killing. The Company plans to initiate a Phase 1 trial in select solid tumors in the second half of 2024. About FG-3175FG-3175 is a c-c motif chemokine receptor 8 (CCR8) targeted antibody under development for treatment of solid tumors highly infiltrated by CCR8-positive T regulatory cells (Tregs). CCR8 is a GPCR with prevalent and highly specific expression on immunosuppressive tumor infiltrating Tregs across different tumor types. FG-3175 is designed to deplete CCR8 Tregs via antibody dependent cellular cytotoxicity (ADCC) in the tumor microenvironment and enhance anti-tumor T cell responses, leading to enhanced anti-tumor activity and potentially improved clinical outcomes for patients in tumors such as Breast, Colorectal, Ovarian and Melanoma. In addition to its ADCC activity FG-3175 also disrupts CCR8 signaling, potentially providing additional benefit by disrupting Treg proliferation and migration into the tumor. The Company plans to submit an Investigational New Drug (IND) application for FG-3175 in 2025. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, a fully human anti-CTGF monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (爱瑞卓®, EVRENZOTM) 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. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. 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 clinical programs for FG-3165 and FG-3175. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential success of FibroGen product candidates, and statements about FibroGen’s plans and objectives and typically are 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 quarterly and annual reports on Form 10-Q and Form 10-K, respectively, 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, CFAVice President, Head of Investor Relations and Corporate FP&Air@fibrogen.com For Media Inquiries:Simon MillerVice President, Marketing and Corporate Communicationsmedia@fibrogen.com

License out/inImmunotherapyINDDrug ApprovalPhase 1

100 Deals associated with Roxadustat

External Link

KEGG	Wiki	ATC	Drug Bank
D10593	-	B03XA05	DB04847

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myelodysplastic Syndromes	Phase 3	US	FibroGen, Inc.	07 Sep 2017
Myelodysplastic Syndromes	Phase 3	AU	FibroGen, Inc.	07 Sep 2017
Myelodysplastic Syndromes	Phase 3	BE	FibroGen, Inc.	07 Sep 2017
Myelodysplastic Syndromes	Phase 3	CA	FibroGen, Inc.	07 Sep 2017
Myelodysplastic Syndromes	Phase 3	DK	FibroGen, Inc.	07 Sep 2017
Myelodysplastic Syndromes	Phase 3	FR	FibroGen, Inc.	07 Sep 2017
Myelodysplastic Syndromes	Phase 3	DE	FibroGen, Inc.	07 Sep 2017
Myelodysplastic Syndromes	Phase 3	IN	FibroGen, Inc.	07 Sep 2017
Myelodysplastic Syndromes	Phase 3	IL	FibroGen, Inc.	07 Sep 2017
Myelodysplastic Syndromes	Phase 3	IT	FibroGen, Inc.	07 Sep 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04655027 (CTgov)	Phase 4	chronic renal failure anemia	25	Roxadustat (Roxadustat)	wqhnyrcrtg(bmzkywksfl) = prupbororh wespugwcyo (uhkiqrzjky, oewmabxknu - xesmiwsftr) View more	-	22 Apr 2024
				rHuEPO (rHuEPO)	wqhnyrcrtg(bmzkywksfl) = ekjpjsqrvn wespugwcyo (uhkiqrzjky, rpriparlas - wkkggavzfl) View more
Pubmed	Phase 3	Chronic Kidney Diseases hemoglobin level \| transferrin saturation	2,354	Roxadustat	qdxjgvwdjk(jilrcmahxr) = 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 mwjcuihqiz (ezrnprdyhk ) View more	-	01 Apr 2024
NCT03263091 (MATTERHORN, GlobeNewswire) Manual	Phase 3	Myelodysplastic Syndromes	62	Roxadustat (higher transfusion burden)	bepvadubek(ussnlnezuz) = mbbfrohmla ccjqvaxjmv (zjxlzdvuge, 20.8 ~ 53.8) View more	Positive	09 Dec 2023
				placebo (higher transfusion burden)	bepvadubek(ussnlnezuz) = znapyktueu ccjqvaxjmv (zjxlzdvuge, 2.4 ~ 30.2) View more
MATTERHORN (ASH2023)	Phase 3	Myelodysplastic Syndromes	140	Roxadustat	zjfictebnh(wrxrjporps) = percentages of pts with TEAEs leading to treatment discontinuation were similar across arms lqnpnwqjaq (jlfezmtbxa ) View more	Positive	09 Dec 2023
				Placebo
ESMO2023 Manual	Phase 3	Neoplasms	140	Roxadustat	gypzyoybir(mtrhohohad) = zhymhlokzo qkxoqqfgag (wekzcnsayd, 13.58 - 20.71)	Non-inferior	21 Oct 2023
				rHuEPO-α	gypzyoybir(mtrhohohad) = qouyrnadhn qkxoqqfgag (wekzcnsayd, 11.34 - 19.50)
ERA2023	Not Applicable	Hypothyroidism	93	Roxadustat	jfwcsmritw(trfhdablqw) = murkdphzhf qppydynrqr (tehgziaezg )	-	15 Jun 2023
NCT02052310 \| NCT02174731 \| NCT02278341 \| NCT02273726 (#2959, ERA2023)	Phase 3	-	4,072	Roxadustat	lgornjfjmi(iynynrjlmf) = The overall percentages of patients with at least one treatment-emergent adverse event were similar for patients treated with roxadustat or ESA across hsCRP quintiles. mzodqmfets (diuktvpgul )	Positive	14 Jun 2023
DOLOMITES, 1517-CL-0610; HIMALAYAS, FGCL-4592-063; SIERRAS, FGCL-4592-064; ROCKIES, D5740C00002 (Pubmed)	Phase 3	Anemia in chronic kidney disease	2,142	Roxadustat	zozudhekrz(zouthgtqqb): HR = 0.79 (95% CI, 0.61 - 1.02) View more	Positive	07 Feb 2023
				Erythropoiesis-Stimulating Agents
Phase 3 Randomized Controlled Trials (ASN2022)	Phase 3	Anemia of renal disease	-	Roxadustat	vlmgtkwtey(jnkphuplxt) = ljwhxcjuou rcbseobffb (zllojpxwiw, -4.37 to -2.59) View more	Positive	03 Nov 2022
ALPINE studies (ASN2022)	Phase 3	Chronic Kidney Diseases	422	Roxadustat	vlqxrhduvi(xrmbzlrvcz) = 27.7 vs 27.5 livpetamer (txrfkmluwx ) View more	Positive	03 Nov 2022
				ESA (epoetin alfa or darbepoetin alfa)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis