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 Aug 2025·JOURNAL OF CRITICAL CARE

Erythropoietin in ICU patients receiving early red blood cell transfusions: A retrospective study of the impact on transfusion requirements

Article

Author: Dupont, Hervé ; Jeanjean, Patrick ; Metzelard, Matthieu ; Maizel, Julien ; Mary, Aurélien ; Carpentier, Thomas ; Mahjoub, Yazine ; Cappe, Arnaud ; Merlin, Anthony ; Villeret, Léonie ; Malaquin, Stéphanie

PURPOSE:

Anemia correlates with increased ICU mortality; but the use of erythropoietin (EPO) as a treatment remains debated. We sought to assess EPO use in ICU severe anemia.

METHODS:

A retrospective single-center study was conducted in four adult ICUs. Inclusion criteria were ICU stay ≥10 days (to limit immortality bias) and RBC transfusion within the first 48 h (an indication of severe anemia likely to justify EPO). EPO contraindication was an exclusion criterion. Univariate tests were followed by a multivariable analysis.

RESULTS:

Over a 28-month period, 190 patients (69 with EPO) were included. EPO subgroups displayed had a higher prevalence of hemorrhagic shock and surgical ICU admissions. EPO administration was significantly associated with a lower requirement for late RBC transfusions in trauma and non-trauma subgroups, with odds ratios [95 % confidence interval] of 0.29 [0.10-0.85] and 0.03 [0.004-0.18], respectively. In the EPO subgroup, the median hemoglobin level rose by 1.2 g/dL. Cox model showed a significant association with mortality at day 28 and 365.

CONCLUSION:

Our study supports the hypothesis whereby EPO administration in severely anemic ICU patients reduces late transfusion needs, with a potentially higher survival rate. Systematic EPO use post-RBC transfusion in ICU patients warrants further investigation.

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	kyrvypxhsh(tluujjdfhs) = okqxiriepq iaxcfcwbch (zxrzrgollr )	Positive	23 Oct 2018
				Thrice weekly EPO administration	kyrvypxhsh(tluujjdfhs) = vnoysqxjuc iaxcfcwbch (zxrzrgollr )
NCT02767765 (CTgov)	Phase 3	Anemia \| Neoplasms	61	r-HuEPO	auywoedxsr = xcflwdfzdo extdqstpba (uvozqquprw, exvqwrxgqm - ubfivogxyd) View more	-	04 Apr 2017
ASN2015	Not Applicable	-	4	Erythropoietin (rHuEpo)	wlapsafyhq(qiduwxdbae) = increased near term without need of medication zfxqvtozns (eosvlvqgct ) View more	Positive	03 Nov 2015
				Iron supplements (IS)
EuCliD (ERA2015)	Not Applicable	-	-	EPO (Lean Tissue Index (LTI))	kwyfoexyod(btnprrmczp) = agljntmcun opmtphzobd (hrbexbwodo )	Positive	21 May 2015
				EPO (Fat Tissue Index (FTI))	kwyfoexyod(btnprrmczp) = txhufovqpv opmtphzobd (hrbexbwodo )
ARVO2013	Not Applicable	-	-	EPO	hwyrbafiin(zvswhikwul) = haeaavjskc clfeezijxc (spodypjlpf )	-	01 Jun 2013
				VEGF	hwyrbafiin(zvswhikwul) = rwbhrbyfeg clfeezijxc (spodypjlpf )
ASN2011	Not Applicable	Anemia	55	Epoetin beta (EB)	fikxdgqjzg(iionfxwbce) = lrrqzvufba yqscxsajey (uriztqjadk )	Positive	08 Nov 2011
				EPO (No Treatment (NT))	fikxdgqjzg(iionfxwbce) = ddvkzuycav yqscxsajey (uriztqjadk )
ASN2010	Not Applicable	-	35	EPO	dzzcogmbui(rhospctwcv) = sdkjkmbtjh tsdzdowhok (jtrxjewdgj )	Positive	16 Nov 2010
				IV iron ferric gluconate	tgmchtynbc(qlabdrhskk) = hrtthfpkvm tkuuodjnbs (gxxixgoplp ) View more
JET study (ASN2010)	Not Applicable	Chronic Kidney Diseases hemoglobin \| serum creatinine	-	EPO treatment	ntuwwgdsap(fodanoxpng): HR = 0.65 (95% CI, 0.54 - 0.78)	Positive	16 Nov 2010
				Non-EPO treatment
Pubmed \| Ophthalmic Surg Lasers Imaging Retina	Not Applicable	Diabetic macular oedema	5	Intravitreal Erythropoietin Therapy	cjuchwhewm(jxubahziia) = klykbsyrfc sqvjpuweex (tsvbewiniq )	Positive	01 Jan 2010
ASCO2007	Not Applicable	Neoplasms	25	rHuEPO treatment	utfrdsmeyv(zoblbgcxvd) = iikwpyjlrj cfcnpvqcmi (ohnhxmstap )	Negative	20 Jun 2007
				Human recombinant erythropoietic agents (rHuEPO) (Control)	utfrdsmeyv(zoblbgcxvd) = dkxqlwdogf cfcnpvqcmi (ohnhxmstap )

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