Febrile Neutropenia - Competitive landscape, 2026

DelveInsight’s, “Febrile Neutropenia - Competitive landscape, 2026,” report provides comprehensive insights about 8+ companies and 10+ drugs in Febrile Neutropenia Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Febrile Neutropenia: Understanding

Febrile Neutropenia: Overview

Neutropenic fever is characterized by fever occurring in the setting of a reduced absolute neutrophil count (ANC), with more severe forms associated with a substantially higher risk of serious infections such as bacteremia. ANC is calculated from the total white blood cell count and the proportions of polymorphonuclear cells and band neutrophils. Clinically, neutropenia may be classified as agranulocytosis, chronic neutropenia, isolated neutropenia when not accompanied by other cytopenias, or granulocytopenia when multiple granulocyte populations are reduced.

In many cases of neutropenic fever, no specific infectious cause can be identified, resulting in a diagnosis of fever of unknown origin. Although bacterial infections are most common, viral and fungal infections may also occur, with pathogens including Staphylococcus, Streptococcus, Enterococcus, Pseudomonas aeruginosa, Acinetobacter, Stenotrophomonas maltophilia, Escherichia coli, and Klebsiella species. Neutropenia may also arise from congenital disorders, drug exposure, including certain antibiotics, antimalarials, anti-inflammatory, psychotropic, antithyroid, cardiovascular, and antiseizure medications, and nutritional deficiencies, particularly involving vitamin B12, folate, or copper. In patients with cancer, infections remain a major cause of morbidity and mortality associated with neutropenic fever.

Neutropenic fever is a common and serious complication of hematologic cancers and cancer treatment, particularly chemotherapy. It occurs when an immunocompromised patient with neutropenia develops an infection due to impaired immune defenses and reduced ability to contain invading pathogens. Damage to protective barriers such as the gastrointestinal or sinus mucosa can further facilitate microbial invasion and increase susceptibility to systemic infections. As a result, neutropenic fever represents a significant clinical concern and requires prompt recognition and management to reduce the risk of severe infectious complications.

Diagnosis of neutropenic fever involves laboratory evaluation, including a complete blood count to assess neutropenia and cultures from blood, urine, throat, and suspected infection sites to identify the causative pathogen. Blood cultures should be obtained from peripheral and catheter sites, when applicable, before initiating empirical broad-spectrum antimicrobial therapy. Additional investigations, such as stool testing, chest imaging, bronchoalveolar lavage, and fungal biomarkers including galactomannan and beta-D-glucan, may be considered based on clinical presentation. Procalcitonin may also support assessment of bacteremia in selected patients. Risk-stratification tools such as the Multinational Association for Supportive Care in Cancer (MASCC) score and Clinical Index of Stable Febrile Neutropenia (CISNE) help distinguish patients at higher risk of complications who may require inpatient management from those who may be suitable for outpatient treatment.

Management of neutropenic fever is guided by overall risk, with high-risk patients requiring prompt inpatient care and intravenous broad-spectrum antimicrobial therapy, while selected low-risk patients may be managed as outpatients with oral empiric antibiotics. High-risk features include prolonged or profound neutropenia, high-risk clinical scores, uncontrolled comorbidities or malignancy, significant hepatic or renal dysfunction, and recent treatment with highly immunosuppressive therapies. Initial treatment for high-risk patients generally involves antipseudomonal beta-lactam monotherapy, with additional coverage for resistant pathogens when clinically indicated; vancomycin is reserved for suspected catheter-related, skin or soft-tissue infections, pneumonia, or hemodynamic instability. Persistent fever despite antibacterial therapy may warrant empiric antifungal treatment. Antimicrobial therapy is continued until clinical and hematologic recovery, while prophylactic antibacterial or antifungal therapy may be considered for selected high-risk patients. Additional preventive measures include appropriate antiviral prophylaxis, vaccination, Pneumocystis prophylaxis when indicated, hepatitis B prophylaxis in high-risk patients, and colony-stimulating factors to reduce the risk of treatment-associated febrile neutropenia.

Report Highlights

1. In July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cavoley, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.

2. In July 2026, Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced that the U.S. Food and Drug Administration (FDA) has approved ENNUMO™ (pegfilgrastim-pccg), a biosimilar to NEULASTA® (pegfilgrastim). ENNUMO is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ENNUMO is approved by the FDA for the same indications as its reference product, NEULASTA.

3. In June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nylaspeg, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

4. In November 2023, the U.S. Food and Drug Administration (FDA) approved Ryzneuta (Efbemalenograstim alfa) indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The approval was based on results of the two pivotal Phase III Study GC-627-04 [NCT02872103] and Study GC-627-05 [NCT03252431] completed in the United States and Europe.

Febrile Neutropenia: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Evive Biotech

Evive Biotech is a global, commercial-stage biopharmaceutical company and a subsidiary of Yifan Pharmaceutical, focused on developing and commercializing innovative biologic therapies across oncology, inflammatory, and metabolic diseases. Founded in 2004, the company has operations across China, the US, Singapore, and Europe, with capabilities spanning research, clinical development, manufacturing, regulatory affairs, and commercialization. Its lead marketed product is Ryzneuta (efbemalenograstim alfa), a long-acting, non-PEGylated G-CSF approved in the US, China, and Europe for reducing chemotherapy-induced neutropenia and the incidence of febrile neutropenia. Evive is also advancing additional biologic candidates through its proprietary technology platforms, with the goal of developing first- or best-in-class therapies for areas of unmet medical need.

Product Description: Ryzneuta

Ryzneuta (efbemalenograstim alfa-vuxw) is a long-acting G-CSF approved to reduce the incidence of infection manifested by febrile neutropenia in adults receiving myelosuppressive anticancer therapy. It stimulates neutrophil production and is administered as a single subcutaneous dose per chemotherapy cycle, at least 24 hours after chemotherapy. Clinical studies demonstrated reductions in severe neutropenia and FN incidence, with efficacy comparable to pegfilgrastim. Ryzneuta is therefore used for prevention of chemotherapy-induced Febrile Neutropenia rather than treatment of established Febrile Neutropenia.

2. Company Overview: Taiho Pharma

Taiho Pharmaceutical Co., Ltd. is a Japan-based, R&D-driven specialty pharmaceutical company and a wholly owned subsidiary of Otsuka Holdings, headquartered in Tokyo. The company primarily focuses on oncology, while also conducting research and development across areas such as immune-related diseases, urology, and other specialty therapeutic fields. Taiho has a strong focus on innovative drug discovery and development and has expanded its global presence through international subsidiaries and strategic partnerships, with the goal of addressing unmet medical needs and improving patient outcomes.

Product Description: ZOSYN

ZOSYN is an injectable antibacterial combination comprising the ?-lactamase inhibitor tazobactam, discovered by Taiho, and the semisynthetic ?-lactam antibiotic piperacillin, discovered by Toyama Chemical Co., Ltd., in an 1:8 potency ratio for intravenous administration. In Japan, Taiho holds the marketing authorization for ZOSYN, while Taisho Toyama Pharmaceutical Co., Ltd. is responsible for its commercialization. ZOSYN, available as tazobactam/piperacillin, has also received approval in Japan for the additional indication of febrile neutropenia for ZOSYN 2.25, ZOSYN 4.5, and the ZOSYN 4.5 intravenous infusion bag formulation.

Febrile Neutropenia: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Akthelia Pharmaceuticals

Akthelia Pharmaceuticals is a preclinical-stage biopharmaceutical company based in Reykjavík, Iceland, focused on developing small-molecule therapies that strengthen epithelial barrier function and enhance innate immune defenses. Its lead program, AKT-011 (Gastrimod), is being developed for chemotherapy-induced febrile neutropenia and related infectious complications, with the aim of reducing gastrointestinal barrier disruption and bacterial translocation during chemotherapy. The company’s broader pipeline explores applications of its host-defense and mucosal-barrier platform across oncology, infectious diseases, inflammation, and wound healing.

Product Description: AKT-011

AKT-011 (Gastrimod) is an oral, small-molecule therapy being developed by Akthelia Pharmaceuticals for the prevention and treatment of chemotherapy-induced febrile neutropenia and associated infectious complications. Unlike conventional approaches that primarily target neutrophil recovery or infections, AKT-011 is designed to strengthen gastrointestinal mucosal barrier integrity and enhance innate immune defenses, with the aim of reducing bacterial translocation from the gut into the bloodstream following chemotherapy-induced mucosal injury. Preclinical studies reported by Akthelia have demonstrated reduced bacterial translocation, supporting further development of the program. AKT-011 is currently in the preclinical stage for the treatment of Febrile neutropenia.

Further product details are provided in the report……..

Febrile Neutropenia Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Febrile Neutropenia Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition – deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Febrile Neutropenia Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Febrile Neutropenia Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Febrile Neutropenia drugs?
• How many Febrile Neutropenia drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Febrile Neutropenia?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Febrile Neutropenia therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Febrile Neutropenia and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• Akthelia Pharmaceuticals
• Evive Biotech
• Amgen
• Armlupeg
• Accord Biopharma

Key Products

• AKT-011
• Ryzneuta
• Neulasta (Pegfilgrastim)
• Armlupeg
• ENUMO