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follitropin alfa

✓ Approved

Cinnagen Co · FSHR · Recombinant Proteins

What is follitropin alfa?

follitropin alfa is a recombinant proteins developed by Cinnagen Co. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

CompanyCinnagen Co
Drug ClassRecombinant Proteins
Molecular TargetFSHR
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Cinnagen Co

Mechanism of Action

Molecular Targets

follitropin alfa acts on 1 molecular target:

FSHRfollicle stimulating hormone receptor (FSHRO, ODG1)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

follitropin alfa is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Reproductive system and breast disordersInfertility male✓ Approved
Reproductive system and breast disordersInfertility female✓ Approved

Related Research Articles

PubMedDrug testing and analysis2026-10-22

Doping Control Analysis of Darbepoetin Alfa Biosimilars in Human Urine, Serum, Plasma, and Dried Blood Spots.

Akiyama Kentaro K, Sakurai Hikaru H, Sato Mitsuhiko M, Momobayashi Atsushi A et al.

Following the patent expiration of the originator darbepoetin alfa, three biosimilar products have been marketed in Japan; however, their detectability by current anti-doping methods has not yet been verified. The present study assessed whether these biosimilars can be detected in human urine, serum, plasma, and dried blood spots (DBS) using the established initial testing procedure and confirmation analysis for erythropoietin-receptor agonists. The originator product and three biosimilars (5 μg, i.v.) were administered to healthy male volunteers. Samples collected up to 72 h postdose were subjected to immunopurification followed by sodium N-lauroyl sarcosinate polyacrylamide-gel electrophoresis (SAR-PAGE) as the initial testing procedure. Confirmation was performed by SAR-PAGE with double blotting for serum and plasma. DBS and urine samples were confirmed by SAR-PAGE using an alternative antibody, and urine samples were further examined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). SAR-PAGE analysis of the pharmaceutical preparations revealed product-specific electrophoretic profiles: two biosimilars migrated slightly above one originator product as diffused smears, whereas the third produced a sharp band comparable to that of another originator product. Similar profiles were observed in postdose samples from all biological matrices, and all biosimilars remained detectable in urine, serum, plasma, and DBS for at least 72 h. Although some biosimilars showed distinct SAR-PAGE banding patterns, product attribution remained limited. LC-MS/MS confirmed administered darbepoetin alfa in the 24 h urine samples but did not detect analyte in lower concentration samples, indicating that its performance was concentration-dependent. Accordingly, SAR-PAGE should incorporate reference standards beyond the originator product, particularly those with different band morphologies.

PMID 42902912
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PubMedGeneral thoracic and cardiovascular surgery cases2026-10-21

Perioperative management of acute type A aortic dissection using extended half-life factor IX (Alprolix) in a patient with severe hemophilia B: a case report.

Kitamura Tessho T, Ryu Yutaro Y, Nakaji Shun S, Taniguchi Shinichiro S

Emergency surgery for acute type A aortic dissection (ATAAD) in patients with severe hemophilia B is extremely rare, and perioperative coagulation management is a major challenge. A 63-year-old man with severe hemophilia B (factor IX activity < 1%) was diagnosed with ATAAD and underwent emergency surgery. Replacement therapy with an extended half-life factor IX product (eftrenonacog alfa; Alprolix) was administered targeting a factor IX activity of 80-100%, and total arch replacement was performed. Cardiopulmonary bypass was performed under standard heparinization conditions. Since rapid measurement of factor IX activity was not possible, postoperative replacement therapy was based primarily on the clinical assessment of hemostasis, with serial activated partial thromboplastin time measurements providing supportive information, whereas intraoperative anticoagulation was managed using standard activated clotting time monitoring. Intra- and postoperative bleeding volumes were within ranges comparable to those observed in standard complex aortic surgery, and the postoperative course was uneventful. The use of an extended half-life factor IX product may be a practical option for perioperative coagulation management during emergency aortic surgery in patients with severe hemophilia B.

PMID 42902440
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PubMedClinical therapeutics2026-10-19

Evaluation of Inpatient Epoetin Alfa Dosing in Patients With Anemia of Chronic Kidney Disease: A Retrospective Cohort Study.

Elhamra Rita R, Streck Timothy T, Iso Tomona T, Hong Lisa T LT

Epoetin alfa labeling and clinical guidelines recommend weight-based dosing for the management of patients with anemia and chronic kidney disease (CKD). However, fixed dosing continues to be used in inpatient practice, and comparative data in hospitalized populations are limited. This study aimed to compare fixed versus weight-based dosing in hospitalized patients with CKD. This retrospective cohort study included hospitalized adult patients with anemia of CKD who were initiated on epoetin alfa at a large academic medical center between January 2014 and August 2024. The primary outcome was hemoglobin exceeding targets (>10 g/dL for non-dialysis-dependent CKD and >11 g/dL for dialysis-dependent CKD). Secondary outcomes included 90-day all-cause mortality, rehospitalization, major adverse cardiovascular events, packed red blood cell transfusion, new or worsening hypertension, and iron deficiency. Among 100 patients (50 in the fixed-dose group and 50 in the weight-based dose group), hemoglobin exceeded targets in 8% and 4% of patients, respectively (P = 0.678). Ninety-day all-cause mortality occurred in 18% and 4% of patients, respectively (P = 0.160); no statistically significant differences were observed in other secondary outcomes. Fixed-dose regimens resulted in higher weight-normalized epoetin alfa doses than weight-based dosing (119.8 vs 67.1 units/kg; P < 0.001). Among hospitalized patients with CKD, fixed-dose epoetin alfa was associated with substantially higher weight-normalized doses and numerically higher rates of hemoglobin exceeding targets and mortality, though differences in clinical outcomes were not statistically significant. These findings suggest that adherence to guideline-recommended weight-based dosing may minimize excessive epoetin alfa dosing. Larger prospective studies are needed to clarify optimal inpatient erythropoiesis-stimulating agent dosing.

PMID 42897033
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PubMedArchivos de la Sociedad Espanola de Oftalmologia2026-10-18

Conjunctival involvement with corneal extension in pediatric mycosis fungoides. Surgical and immunomodulatory management.

Montoya Alicia Cárceles AC, Tarazona Jaimes Claudia P CP, Valero Daniel Romero DR

A 13-year-old boy with mycosis fungoides (MF) presented with uncommon ophthalmic involvement. Clinical examination revealed a vascularized conjunctival nodule with corneal extension involving the visual axis and causing severe visual impairment. Initial treatment with topical corticosteroids and tacrolimus showed poor response. Complete surgical excision was performed for diagnostic and therapeutic purposes. Histopathological analysis confirmed progression to T-cell lymphoma. Adjuvant treatment with topical interferon alfa-2b was initiated. After two years of follow-up, no recurrence was observed, with partial visual improvement. This case highlights a rare pediatric presentation and central corneal involvement, both infrequently described. Combined surgical and immunomodulatory treatment achieved adequate local control, although residual sequelae limiting visual acuity persisted.

PMID 42892324
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PubMedDrugs in context2026-10-17

Biochemical and clinical changes during enzymatic replacement therapy in hypophosphatasia: three real-world cases in Spain.

Marbán Calzón Mercedes M, Aguado Acín María Pilar MP, Carrillo-Linares Juan Luis JL, González Jimeno Alicia A et al.

Hypophosphatasia (HPP) is a rare recessive or dominant autosomal disease caused by loss-of-function variants in the ALPL gene, which encodes tissue-nonspecific alkaline phosphatase (TNSALP). Molecules involved in the pathogenesis of HPP are alkaline phosphatase (ALP), inorganic pyrophosphate (PPi; an inhibitor of bone mineralization), pyridoxal-5'-phosphate (PLP; responsible for the neurological complications) and phosphoethanolamine. Asfotase alfa is a recombinant, bone-targeted, human TNSALP approved to treat patients with HPP. Its clinical effectiveness has been demonstrated in real-world settings across international HPP registries. However, evidence from routine clinical practice in Spain is lacking. Here, we report three Spanish cases of HPP treated successfully with asfotase alfa: a girl diagnosed at 3 months; a woman diagnosed at age 47 years; and a 27-year-old woman with paediatric-onset symptoms. In all cases, asfotase alfa treatment was associated with an increase in serum ALP, marked reductions in plasma PPi and PLP, and marked improvements in symptoms and physical performance. Our series of HPP cases confirms the beneficial effects of asfotase alfa on biochemical and clinical outcomes, consistent with evidence from randomized clinical trials.

PMID 42891438
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PubMedDiabetes, obesity, and cardiometabolic CARE2026-10-17

Comparative Effectiveness of Once-Weekly Insulin Efsitora Alfa in Patients With Type 2 Diabetes: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Hammad Noha N, Abdelaziz Ahmed A, Abouzkaly Fatma F, Abdulrahman Saad Omar O et al.

Achieving and maintaining a glycated hemoglobin (HbA1c) level <7% in patients with type 2 diabetes (T2D) remains challenging, partly because of the daily insulin injection burden. Insulin efsitora alfa is a long-acting insulin Fc-fusion protein designed for once-weekly administration, which may reduce injection burden. The purpose of this analysis is to evaluate the efficacy and safety of once-weekly insulin efsitora alfa compared with once-daily basal insulin in adults with T2D, stratified by baseline insulin use. PubMed, Web of Science, Scopus, and Cochrane CENTRAL were searched from inception through July 2025, along with ClinicalTrials.gov. Randomized controlled trials (RCTs) enrolling adults with T2D that compared once-weekly insulin efsitora alfa with once-daily basal insulin for ≥12 weeks were included. Six trials met eligibility criteria. Two authors independently extracted data using a standardized form. The primary outcome was the mean change in HbA1c (%). Secondary outcomes included fasting plasma glucose, body weight, time in range, hypoglycemia, and adverse events. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Six RCTs, including 4,116 participants, were analyzed. Efsitora demonstrated HbA1c reduction comparable to daily basal insulin in insulin-treated patients (mean difference [MD] -0.06% [95% CI -0.24, 0.11]; P = 0.48) and insulin-naive patients (MD -0.03% [95% CI -0.12, 0.06]; P = 0.51). Nocturnal hypoglycemia episodes were fewer with efsitora in both insulin-treated patients (risk ratio [RR] 0.82 [95% CI 0.68, 0.98]; P = 0.03) and insulin-naive patients (RR 0.71 [95% CI 0.52, 0.95]; P = 0.02). All included trials were open-label, and follow-up duration was limited. Long-term outcomes, real-world adherence, and cost-effectiveness could not be fully assessed. Once-weekly insulin efsitora alfa demonstrates glycemic control and overall safety comparable to once-daily basal insulin in adults with T2D, with fewer nocturnal hypoglycemia episodes. Longer-term RCTs and real-world studies are needed to define its long-term clinical and economic impact.

PMID 42890470
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