Delving into the Latest Updates on Recombinant erythropoietin(Bio-Gal) with Synapse

Overview

Basic Info

Drug Type

Colony-stimulating factors

Synonyms

EPO, Recombinant erythropoietin, rHuEPO

Target

EPO receptor

Action

agonists, stimulants

Mechanism

EPO receptor agonists(Erythropoietin receptor agonists), Erythropoiesis stimulants(Erythropoiesis stimulants)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication-

Inactive Indication

Multiple Myeloma

Originator Organization

Bio-Gal

Active Organization-

Inactive Organization

XTL Biopharmaceuticals Ltd.

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

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In a prospective, multicenter clinical study, we randomly assigned (in a 1:1 ratio) 100 PD patients who had received erythropoiesis-stimulating agent therapy for at least 4 weeks to receive either roxadustat or erythropoietin (EPO) for 48 weeks. The blood lipids, hemoglobin, blood pressure, blood glucose, iron metabolism and inflammatory factors were compared between the two groups at 0, 2, 4, 8, 12, 16, 20, 24 and 48 weeks, respectively.

RESULTS:

At start of switching to roxadustat, hemoglobin seemed to rise a little faster (102.8 ± 15.4 vs. 97.1 ± 17.3 g/L at 2 weeks, p > 0.05), but there was no significant difference in hemoglobin change between the two groups over the course of observation (p = 0.185). At the early stage of the study (12 weeks), the transferrin saturation (TSAT) of roxadustat group decreased significantly from the baseline (32.7 (20.6) vs. 22.1 (18.7)%, p = 0.001). At the end of the study period (48 weeks), total cholesterol (3.89 ± 0.92 vs. 4.52 ± 1.14 mmol/L, p = 0.012), low density lipoprotein cholesterol (2.24 ± 0.74 vs. 2.63 ± 0.82 mmol/L, p = 0.045) and triglyceride (1.35 (0.86) vs. 1.89 (1.27) mmol/l, p = 0.013) in roxadustat group were significantly lower than those in EPO group.

CONCLUSIONS:

Roxadustat not only can improve anemia and iron metabolism, but also can reduce serum cholesterol and triglyceride levels in PD patients after switching from the EPO.

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Therapeutic effects of erythropoietin-alginate/chitosan hydrogel on impaired male rat fertility after spinal cord injury

Article

Author: Rasekh, Morteza ; Akbari, Ghasem ; Sadeghinezhad, Javad ; Gilanpour, Hassan ; Mortazavi, Pejman

BACKGROUND:

Infertility is a significant issue in spinal cord injury (SCI) patients. Men with SCI often experience erectile and ejaculatory dysfunctions, and low sperm quality leading to impaired fertility. In this study, we investigated the effectiveness of Erythropoietin (EPO)alginate/chitosan (CH-AL) hydrogel on SCI-induced male rat infertility.

METHODS:

Twenty-four male Wistar rats were divided into three groups: Sham, SCI-induced group without any further intervention (Negative control, NC), and a treatment group receiving 10,000 IU/kg EPO-CH/AL hydrogel (EPO group), immediately following SCI induction. Sperm parameters, oxidative stress markers, apoptosis, and histopathological changes in animal testes were analyzed.

RESULTS:

Sperm viability and motility significantly decreased in the NC group compared to the sham group (p < 0.01). Treatment with 10,000 IU/kg EPO-CH/AL hydrogel significantly improved sperm viability and motility compared to the NC group (p < 0.05). Malondialdehyde (MDA) and Superoxide dismutase (SOD) levels were elevated and reduced, respectively, in the NC group compared to the sham group. Treatment with EPO-CH/AL hydrogel group, significantly decreased MDA level and increased SOD levels compared to the NC group (p < 0.05). Apoptosis analysis revealed upregulation of Bcl-2 and downregulation of Bax genes in EPO-CH/AL hydrogel compared to the NC group (p < 0.05). Histological analysis showed that the EPO-CH/AL hydrogel improved depletion of germ cell population and Luminal spaces compared to NC group but did not fully restore normal histology.

CONCLUSION:

EPO-CH/AL hydrogel effectively improves sperm viability and motility, reduces oxidative stress, and mitigates apoptosis, demonstrating its potential as a therapeutic strategy for SCI-induced infertility.

01 Mar 2025·Metabolism open

Anemia in diabetes mellitus: Pathogenetic aspects and the value of early erythropoietin therapy

Review

Author: Tsilingiris, Dimitrios ; Gavriilidis, Efstratios ; Ritis, Konstantinos ; Antoniadou, Christina

Anemia is a frequent, yet increasingly recognized, comorbidity in diabetes mellitus (DM), with prevalence often driven by multifactorial mechanisms. Hematinic deficiencies, common in this population, may arise from associated comorbidities or medications, such as metformin, as well as other drugs commonly employed for DM-related conditions. Among contributing factors, diabetic kidney disease (DKD) plays a pivotal role, with anemia developing more frequently and being more pronounced in earlier stages, than in CKD of other causes. This enhanced susceptibility stems primarily from the combined impact of impaired renal oxygen sensing and deficient erythropoietin (EPO) production linked to tubulointerstitial fibrosis. Additional mechanisms comprise glomerular dysfunction, shortened erythrocyte lifespan, uremia-induced bone marrow suppression, and increased bleeding risk. DM is also recognized as a chronic low-grade inflammatory condition, with its inflammatory burden driving iron maldistribution, suppression of erythropoiesis, and resistance to EPO. The diagnostic approach of anemia in DM mirrors that in the general population. Addressing modifiable causes such as hematinic deficiencies, and other chronic conditions, such as DKD and bone marrow disorders, is paramount. In total, the underlying pathophysiology of anemia in DM primarily reflects a state of absolute or relative EPO deficiency and/or diminished bone marrow responsiveness, effectively corresponding to 'anemia of chronic disease. Early initiation of EPO therapy, even in DM patients without overt DKD, may mitigate disease progression and improve outcomes. Future research should focus on diabetes-specific strategies integrating optimal EPO use, potentially implementing targeted management of renal and inflammatory contributors to anemia.

1

News (Medical) associated with Recombinant erythropoietin(Bio-Gal)

23 May 2021

·www.globenewswire.com

HAGENS BERMAN Reminds FibroGen (FGEN) Investors of

SAN FRANCISCO, May 23, 2021 (GLOBE NEWSWIRE) -- Hagens Berman urges FibroGen, Inc. (NASDAQ: FGEN) investors with significant losses to submit your losses now. Class Period: Oct. 18, 2017 – Apr. 6, 2021Lead Plaintiff Deadline: June 11, 2021Visit: Contact An Attorney Now: FGEN@hbsslaw.com 844-916-0895 FibroGen, Inc. (NASDAQ: FGEN) Securities Fraud Action: The complaint centers on FibroGen’s presentation of false data of roxadustat to make the anemia drug look safer than it is. Throughout the Class Period, FibroGen touted the prospects of roxadustat. A key selling point for the drug was its purported heart safety as compared to standard of care erythropoietin (EPO) injectable therapies, which cannot be proscribed to a variety of patients at risk of major cardiac events. To support this marketing edge, FibroGen presented data from phase 3 trials purportedly showing roxadustat was safer than EPO, among other at risk populations, in incident dialysis patients. But after the market closed on Apr. 6, 2021, FibroGen stunningly admitted to altering stratification factors to make roxadustat’s hazard ratios indicate lower risk relative to EPO. As a result of the data manipulation, FibroGen CEO Enrique Conterno admitted that the company can no longer say its drug was safer than EPO in incident dialysis patients. In response to this news, several analysts slashed their FibroGen share price targets and reduced their investment recommendations. On this news, the Company’s share price fell over 43%, to close at $19.74 per share on Apr. 7, 2021. Shares continued to fall 5% on Apr. 8, 2021, on heavy volume. “We’re focused on investors’ losses and proving FibroGen senior management intentionally manipulated the safety-related data for its anemia drug,” said Reed Kathrein, the Hagens Berman partner leading the investigation. If you are a FibroGen investor and have significant losses, or have knowledge that may assist the firm’s investigation, click here to discuss your legal rights with Hagens Berman. Whistleblowers: Persons with non-public information regarding FibroGen should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email FGEN@hbsslaw.com. About Hagens BermanHagens Berman is a national law firm with eight offices in eight cities around the country and over eighty attorneys. The firm represents investors, whistleblowers, workers and consumers in complex litigation. More about the firm and its successes is located at hbsslaw.com. For the latest news visit our newsroom or follow us on Twitter at @classactionlaw. Contact:Reed Kathrein, 844-916-0895

100 Deals associated with Recombinant erythropoietin(Bio-Gal)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Myeloma	Phase 1	-	XTL Biopharmaceuticals Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2018	Not Applicable	Hgb levels	60	Daily EPO administration	kjiygkvdvb(enotswovuq) = fnmeounwzr vdmfrtzeyy (mrddlfaiby )	Positive	23 Oct 2018
				Thrice weekly EPO administration	kjiygkvdvb(enotswovuq) = bxufiwjnns vdmfrtzeyy (mrddlfaiby )
NCT02767765 (CTgov)	Phase 3	Anemia \| Neoplasms	61	r-HuEPO	abycdplbcs = unprzvskmx bmtnkdpkcj (yxlpbuddtw, sricndbecf - rckxcrdooe) View more	-	04 Apr 2017
ASN2015	Not Applicable	-	4	Erythropoietin (rHuEpo)	muayhezhva(mjmyswazbf) = increased near term without need of medication ixcnnpriav (ylhkwvnqvq ) View more	Positive	03 Nov 2015
				Iron supplements (IS)
EuCliD (ERA2015)	Not Applicable	-	-	EPO (Lean Tissue Index (LTI))	xttrsywxiy(knkbigajvi) = tocbcxhhgm abeojuvnuv (rzaraxdaca )	Positive	21 May 2015
				EPO (Fat Tissue Index (FTI))	xttrsywxiy(knkbigajvi) = jivsolxdib abeojuvnuv (rzaraxdaca )
ARVO2013	Not Applicable	-	-	EPO	hwrqperlie(rpxamaoasj) = lnyidymreu njzauuhjhv (xntcbgtccq )	-	01 Jun 2013
				VEGF	hwrqperlie(rpxamaoasj) = azwojzvtvn njzauuhjhv (xntcbgtccq )
ASN2011	Not Applicable	Anemia	55	Epoetin beta (EB)	qrfhhlbtqp(nrhbunncoo) = punjvmkqxo zzodxdrxgt (mjcfkbbrfx )	Positive	08 Nov 2011
				EPO (No Treatment (NT))	qrfhhlbtqp(nrhbunncoo) = kpnvcrredu zzodxdrxgt (mjcfkbbrfx )
JET study (ASN2010)	Not Applicable	Chronic Kidney Diseases hemoglobin \| serum creatinine	-	EPO treatment	uilpktrkrl(suezqerpoo): HR = 0.65 (95% CI, 0.54 - 0.78)	Positive	16 Nov 2010
				Non-EPO treatment
ASN2010	Not Applicable	-	35	EPO	xajtylkzgl(xanvhppfsv) = annjmstbvk gmohspsdfb (wgijnmxsmw )	Positive	16 Nov 2010
				IV iron ferric gluconate	ogjkdbasup(halpsrwcco) = xmksycqgrp mpjccphmwe (ziarujikvg ) View more
Pubmed \| Ophthalmic Surg Lasers Imaging Retina	Not Applicable	Diabetic macular oedema	5	Intravitreal Erythropoietin Therapy	rhfqswbfvw(iavesesixp) = dxqyrwrnop kasfvqjldx (hffofvhxhm )	Positive	01 Jan 2010
ASCO2007	Not Applicable	Neoplasms	25	rHuEPO treatment	cmlzlyieni(zrkswyiium) = zizghwexps hmxfvkquxt (cftmzxktlg )	Negative	20 Jun 2007
				Human recombinant erythropoietic agents (rHuEPO) (Control)	cmlzlyieni(zrkswyiium) = csvxawmwso hmxfvkquxt (cftmzxktlg )

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