Drug Database
EP

epoetin alfa (GerEpo / epoetin alfa, NCPC)

✓ Approved

North China Pharmaceutical · EPOR · Recombinant Proteins

What is epoetin alfa?

epoetin alfa is a recombinant proteins developed by North China Pharmaceutical. It is approved for therapeutic indications via injectable (others) or intravenous (iv) or subcutaneous injection.

Drug Profile

Brand NamesGerEpo, epoetin alfa, NCPC
CompanyNorth China Pharmaceutical
Drug ClassRecombinant Proteins
Molecular TargetEPOR
RouteInjectable (Others), Intravenous (IV), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, North China Pharmaceutical

Mechanism of Action

Molecular Targets

epoetin alfa acts on 1 molecular target:

EPORerythropoietin receptor (EPO-R)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

epoetin alfa is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersNephrogenic anaemia✓ Approved

Related Research Articles

PubMedChild's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery2026-09-19

Conversion of a ventricular rickham reservoir to a subcutaneous chest port for repeated intraventricular enzyme replacement therapy: technical note and surgical considerations.

Gopalka Mahie M, Manocha Samiya S, Romanski Kathleen K, Hoeman Erin E et al.

Cerliponase alfa enzyme replacement therapy has transformed the management of neuronal ceroid lipofuscinosis type 2 (CLN2) disease but requires lifelong cerebrospinal fluid (CSF) access for repeated intraventricular infusions. Conventional scalp-based ventricular reservoirs are associated with complications including infection, mechanical deterioration, and device revision related to repeated puncture. Chest port-mediated ventricular access has emerged as a potential alternative; however, detailed operative descriptions remain limited. We describe operative considerations and stepwise technique for establishing ventricular access using a Rickham reservoir connected via shunt tubing to a subcutaneous chest port system for repeated intraventricular cerliponase alfa infusion. Illustrative clinical experience demonstrates durable long-term use of this configuration. Key technical elements include neuronavigation-guided ventricular catheter placement, creation of a subcutaneous or subfascial chest pocket depending on patient body habitus, incorporation of strain-relief loops to reduce catheter tension, and systematic testing of the completed construct. The resulting system allows reliable ventricular access via a chest port while preserving ventricular catheter integrity. Chest port-mediated ventricular access represents a feasible and durable strategy for long-term intraventricular therapy in CLN2 disease. Dissemination of operative technique may facilitate broader adoption and support reliable delivery of enzyme replacement therapy for patients requiring lifelong treatment.

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PubMedMedicine2026-09-19

Intractable hepatic hydrothorax eliminated by thoraco-peritoneal connection: A case report.

Lang Qing Q, Ben Xiaoyuan X, Wang Chengkang C, Zhang Jiebing J et al.

Hepatic hydrothorax occurs in patients with decompensated cirrhosis and has a significantly adverse prognosis. However, several treatments, including indwelling pleural catheters, trans jugular intrahepatic systemic shunts, and automatic low-flow ascites pumps (Alfa pumps), have been utilized to relieve pleural effusion, but these methods often cause severe complications. We report the first case of using thoraco-peritoneal connection to manage hepatic hydrothorax in a cirrhotic patient without an unfavorable outcome. A 55-year-old yellow-skinned female patient with alcoholic cirrhosis suffering from hepatic hydrothorax was admitted to the hospital. She presented with recurrent yellowish complexion, anorexia, chest tightness, and shortness of breath. The definitive diagnosis encompassed liver failure, alcoholic cirrhosis in a decompensated state, esophageal varices, portal hypertension, ascites, hepatic hydrothorax, hypersplenism, cholecystolithiasis accompanied by cholecystitis, pulmonary nodules, and coronary atherosclerosis. A thoracic drainage catheter and an abdominal puncture indwelling needle were connected to allow the pleural effusion to continuously flow into the abdominal cavity. The patient showed rapid improvement in nutritional status, urine output, and a decrease in pleural effusion. Subsequently, pleural effusion did not increase, and the connection was removed 1 month later. Hydrothorax and ascites were examined by color Doppler ultrasound every 2 months. Liver function and coagulation function continued to improve. The patient resumed normal daily activities after 6 months. The management of hepatic hydrothorax remains an area requiring further investigation. Thoraco - peritoneal connection might represent a medical strategy for the management of hepatic hydrothorax in cirrhotic patients with a favorable safety profile.

PMID 42760719
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PubMedGenes & diseases2026-09-18

Efineptakin alfa (NT-I7) improves overall survival and induces immune niches in murine tumors.

Dinh Trang T, Lee Judong J, Islam Sidra S, Nanda Namita N et al.

Tertiary lymphoid structures (TLSs) are emerging as good predictive biomarkers of response to cancer immunotherapy. However, therapeutic strategies to induce these structures are currently limited. We evaluated the therapeutic benefit of efineptakin alfa (NT-I7), a long-acting form of IL-7, as well as its ability to remodel the tumor immune microenvironment and induce TLSs in murine lung and colorectal tumor models. NT-I7 improved overall survival in tumor-bearing mice. It also increased the abundance of T, B, dendritic cells, and stem-like CD8 T cells and promoted the formation of immune aggregates in the tumor microenvironment (TME). Stem-like CD8 T cells were preferentially located in the immune aggregates. Spatial transcriptomic analyses of the TME further demonstrated that the immune aggregates induced by NT-I7 included TLS-like structures with enrichment of Cd274 (PD-L1) transcripts and genes involved in antigen processing and presentation. Up-regulation of Cd274 in the TLS-like structures may provide opportunities for synergy between NT-I7 and PD-1-targeted immunotherapy.

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PubMedCurrent hematologic malignancy reports2026-09-18

Molecular Response, Event-Free Survival, and Treatment-Free Remission in Myeloproliferative Neoplasms: Update and Review with Insights from MPN Asia 2026.

Abu-Zeinah Ghaith G, Hobbs Gabriela S GS, Rampal Raajit K RK, Lee Sung-Eun SE et al.

Therapeutic goals in BCR::ABL1-negative myeloproliferative neoplasms (MPNs) are evolving to include biologically anchored measures of disease modification with control of blood counts, splenomegaly, and symptoms. Disease modification endpoints and their linkage to survival in MPNs were central to the framework of MPN Asia 2026, which took place in Seoul. This review summarizes key themes from MPN Asia 2026 and relevant recent literature, examining the evolving roles of molecular response and long-term clinical benefits within a broader disease-modification framework across polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF). Clinical trials with ropeginterferon alfa-2b were central to the discussions given these studies have contributed to the evolving paradigm of disease modification in MPNs, underscoring the importance of molecular response and event-free survival (EFS) in MPN management. In PV, ropeginterferon alfa-2b treatment provides a clinical model linking durable hematologic control and deep JAK2V617F variant allele frequency (VAF) reduction with improved long-term outcomes such as EFS, and prospective treatment-discontinuation strategies. Data from Europe and Asia supports the importance of early disease control, adequate interferon exposure, and longitudinal molecular monitoring. In ET, randomized data with ropeginterferon alfa-2b and emerging new treatment approaches such as lysine-specific demethylase 1 inhibition and mutant CALR-directed therapy are incorporating molecular endpoints into clinical development. However, the association between VAF reduction and thrombosis prevention, disease modification, EFS, and treatment-free remission (TFR) need to be elucidated. In MF, molecular profiling is already integral to prognostication and treatment selection, and disease modification assessment will likely require endpoints encompassing more than symptoms and spleen response, such as anemia response, bone marrow fibrosis change, clonal evolution, patient-reported outcomes, and importantly progression-free and overall survival. Molecular response, clonal suppression, prevention of vascular and progression events, survival outcomes such as EFS and TFR play increasingly important roles in MPN management.

PMID 42758401
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PubMedFrontiers in neurology2026-09-18

Efgartigimod-alfa therapy in acetylcholine receptor antibody myasthenia gravis: Romanian experience.

Grecu Nicolae N, Mihalache Oana Antonia OA, Davidescu Eugenia Irene EI, Bălașa Rodica R et al.

Efgartigimod alfa, the first neonatal Fc receptor inhibitor approved for the treatment of acetylcholine receptor antibody (AChR)-positive generalized myasthenia gravis (MG), has demonstrated efficacy in randomized controlled trials. However, real-world data, particularly from Eastern Europe, remain limited. This prospective, multicenter study enrolled AChR-positive generalized MG patients treated with efgartigimod across six Romanian university hospitals between March 2024 and September 2025. Outcomes were assessed using the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, the Quantitative Myasthenia Gravis (QMG) score, and the Myasthenia Gravis Quality of Life 15-item revised scale (MG-QoL15r). Clinically meaningful improvement (CMI), minimal symptom expression (MSE), patient-acceptable symptom state (PASS), subdomain response, and corticosteroid sparing were evaluated. Thirty-nine patients completed at least one treatment cycle, receiving a total of 210 cycles. In cycle 1, CMI rates were 89.7% for MG-ADL and 74.4% for QMG, with a median MG-ADL reduction of 4.0 points (p < 0.001); 69.2% achieved CMI after a single infusion. Composite PASS increased from 25.6% in cycle 1 to 54.5% in cycle 8. Subdomain analysis showed improvements across all domains for both the MG-ADL and the QMG, with the exception of QMG respiratory. Among patients on corticosteroids (n = 29), median prednisone dose decreased from 20.0 to 10.0 mg/day (p = 0.004), with 58.6% achieving reduction or discontinuation. This first Eastern European real-world efgartigimod-treated cohort confirms rapid and sustained improvement and corticosteroid sparing, consistent with prior evidence.

PMID 42756311
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PubMedJournal of thrombosis and thrombolysis2026-09-17

Thrombotic and ischemic event reporting with anticoagulant reversal agents: a multi-agent FAERS pharmacovigilance study.

Isleyen Hasan Burak HB, Yavuz Sevil Tugrul ST, Acikgoz Nusret N, Ozdemir Ramazan R et al.

Anticoagulant reversal is usually performed during severe bleeding in patients who may remain at substantial thrombotic risk. We evaluated thrombotic and ischemic adverse-event reporting for andexanet alfa, idarucizumab, and a prothrombin complex concentrate (PCC) exposure set in the FDA Adverse Event Reporting System (FAERS). Public quarterly FAERS ASCII files from 2018Q2 through 2026Q1 were analyzed according to reporting principles for disproportionality analyses. Reports were deduplicated at case level. The primary exposure definition was primary or secondary suspect (PS/SS) reversal-agent reporting; all-role exposure, core-endpoint, and product/formulation-specific PCC analyses were sensitivity analyses. Exact Medical Dictionary for Regulatory Activities (MedDRA) preferred-term dictionaries defined thrombotic and ischemic endpoints. Reporting odds ratios (RORs), proportional reporting ratios (PRRs), and information component lower bounds (IC025) were calculated. The dataset included 11,586,364 deduplicated reports. PS/SS exposure sets included 1,086 andexanet alfa, 1,163 idarucizumab, and 1,080 PCC reports. The thrombotic/ischemic composite was reported in 371 andexanet reports (ROR 32.72, 95% CI 28.87-37.10), 156 idarucizumab reports (ROR 9.78, 95% CI 8.26-11.57), and 231 PCC reports (ROR 17.16, 95% CI 14.84-19.85). Ischemic stroke was the strongest andexanet component signal (ROR 120.38, 95% CI 103.88-139.49). FAERS reports showed disproportionate thrombotic and ischemic reporting for all three reversal-agent exposure sets, with a prominent andexanet signal for ischemic stroke. These findings are hypothesis-generating and should not be interpreted as incidence, causality, or a direct comparative clinical-risk estimate.

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