Sepsis Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Sepsis pipeline constitutes 25+ key companies continuously working towards developing 30+ Sepsis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Sepsis Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Sepsis Market.

The Sepsis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Sepsis Pipeline Report: https://www.delveinsight.com/sample-request/sepsis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Sepsis treatment therapies with a considerable amount of success over the years.
• Sepsis companies working in the treatment market are La Jolla Pharmaceuticals/Innoviva Specialty Therapeutics, Ono Pharmaceuticals, Vivacelle Bio, Inotrem, Fe Pharmaceuticals, Revagenix, Northern Therapeutics, Recce Pharmaceuticals, Artcline GmbH, Inotrem, Shionogi, SciClone Pharmaceuticals, and others, are developing therapies for the Sepsis treatment
• Emerging Sepsis therapies in the different phases of clinical trials are- GIAPREZA (angiotensin II), Onoact Injection (Landiolol hydrochloride), VBI-S, Nangibotide, FEP-100, Research programme, GEM00220, RECCE 327, ARTICE therapy, Nangibotide, Cefiderocol, Thymosin alpha, and others are expected to have a significant impact on the Sepsis market in the coming years.
• In July 2025, A ready-to-infuse therapy for sepsis represents a significant step forward in the management of time-sensitive infections. Hikma Pharmaceuticals PLC announced that the U.S. Food and Drug Administration (FDA) has approved a new formulation of vancomycin, marketed as TYZAVANTM (Vancomycin Injection, USP). This first-of-its-kind, ready-to-infuse vancomycin is a glycopeptide antibacterial indicated for use in adult and pediatric patients aged one month and older, where appropriate dosing can be achieved. TYZAVANTM is approved for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections.
• In April 2025, Vivacelle Bio announced that a study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia. Sepsis is a serious condition resulting from the presence of harmful microorganisms in the blood or other tissues and the body's response to their presence, leading to the malfunctioning of various organs.
• In March 2025, Accelerate Diagnostics announced the submission of its Accelerate WAVETM system and positive blood culture gram-negative test kit to the FDA for 510(k) clearance. The WAVE system offers rapid antimicrobial susceptibility testing (AST) from positive blood cultures and bacterial isolate colonies, providing accurate results in about 4.5 hours to enable same-shift targeted antimicrobial therapy for patients with serious infections.
• In November 2024, Soon after securing $57 million in funding, Inflammatix launched a clinical trial to assess its diagnostic technology for managing patients with suspected acute infections or sepsis. The TIMED trial (NCT06637904) will utilize the company's TriVerity test-a blood-based diagnostic that examines 29 messenger RNAs (mRNAs) to quickly evaluate the body's immune response to infection. When run on Inflammatix's benchtop, cartridge-based analyzer, Myrna, the test enables emergency department clinicians to identify the type of infection and determine if sepsis is likely to develop.
• In May 2024, A clinical trial funded by the US National Institutes of Health (NIH) suggests that intravenous acetaminophen may benefit sepsis patients. In this mid-stage trial, 447 adult sepsis patients with respiratory or circulatory organ dysfunction were enrolled. Conducted from October 2021 to April 2023, the study involved participants admitted to 40 academic hospitals across the US. They were randomly assigned to receive either intravenous acetaminophen or a placebo every six hours for five days. The primary focus was on the number of patients surviving without the need for organ support, such as mechanical ventilation or kidney failure treatment.
• In April 2024, Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage company focused on macrophage reprogramming immunotherapy, today reported positive indications of effect and safety results from its Phase II study of AllocetraTM in sepsis patients, with 120 patients enrolled.
• In April 2024, AdrenoMed announced that the US FDA has granted Fast Track designation to its lead product candidate, enibarcimab, a first-in-class non-neutralizing monoclonal antibody, for the treatment of septic shock.

Sepsis Overview
Sepsis is a life-threatening medical condition that occurs when the body's response to an infection triggers widespread inflammation, leading to tissue damage, organ failure, or even death. It can result from infections in any part of the body-such as the lungs, urinary tract, skin, or abdomen. Early symptoms include fever, rapid heart rate, confusion, and shortness of breath. Prompt diagnosis and treatment with antibiotics, fluids, and supportive care are crucial to improve survival and prevent complications.

Get a Free Sample PDF Report to know more about Sepsis Pipeline Therapeutic Assessment-
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Emerging Sepsis Drugs Under Different Phases of Clinical Development Include:
• GIAPREZA (angiotensin II): La Jolla Pharmaceuticals/Innoviva Specialty Therapeutics
• Onoact Injection (Landiolol hydrochloride): Ono Pharmaceuticals
• VBI-S: Vivacelle Bio
• Nangibotide: Inotrem

Sepsis Route of Administration
Sepsis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Sepsis Molecule Type
Sepsis Products have been categorized under various Molecule types, such as
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Sepsis Pipeline Therapeutics Assessment
• Sepsis Assessment by Product Type
• Sepsis By Stage and Product Type
• Sepsis Assessment by Route of Administration
• Sepsis By Stage and Route of Administration
• Sepsis Assessment by Molecule Type
• Sepsis by Stage and Molecule Type

DelveInsight's Sepsis Report covers around 30+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Sepsis product details are provided in the report. Download the Sepsis pipeline report to learn more about the emerging Sepsis therapies
https://www.delveinsight.com/sample-request/sepsis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Sepsis Therapeutics Market include:
Key companies developing therapies for Sepsis are - F. Hoffmann-La Roche Ltd, Pfizer Inc., GSK Plc, Viatris Inc. (Mylan Inc.), AbbVie Inc (Allergan Pharmaceuticals Private Limited), Asahi Kasei Corporation, RegeneRx, Inotrem SAEndacea Inc., Adrenomed AG, and others.

Sepsis Pipeline Analysis:
The Sepsis pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Sepsis with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Sepsis Treatment.
• Sepsis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Sepsis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Sepsis market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Sepsis drugs and therapies
https://www.delveinsight.com/sample-request/sepsis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Sepsis Pipeline Market Drivers
• Increase in awareness of Sepsis, increase in the Research and Development activities are some of the important factors that are fueling the Sepsis Market.

Sepsis Pipeline Market Barriers
• However, side effects associated with the treatment, economic burden associated with the disease and other factors are creating obstacles in the Sepsis Market growth.

Scope of Sepsis Pipeline Drug Insight
• Coverage: Global
• Key Sepsis Companies: La Jolla Pharmaceuticals/Innoviva Specialty Therapeutics, Ono Pharmaceuticals, Vivacelle Bio, Inotrem, Fe Pharmaceuticals, Revagenix, Northern Therapeutics, Recce Pharmaceuticals, Artcline GmbH, Inotrem, Shionogi, SciClone Pharmaceuticals, and others
• Key Sepsis Therapies: GIAPREZA (angiotensin II), Onoact Injection (Landiolol hydrochloride), VBI-S, Nangibotide, FEP-100, Research programme, GEM00220, RECCE 327, ARTICE therapy, Nangibotide, Cefiderocol, Thymosin alpha, and others
• Sepsis Therapeutic Assessment: Sepsis current marketed and Sepsis emerging therapies
• Sepsis Market Dynamics: Sepsis market drivers and Sepsis market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

This release was published on openPR.