Sepsis

Infectious Diseases
20
Pipeline Programs
26
Companies
38
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
8
0
2
1
6
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
1100%
+ 35 programs with unclassified modality

Competitive Landscape

25 companies ranked by most advanced pipeline stage

M&
Merck & Co.RAHWAY, NJ
4 programs
2
1
1
ImipenemPhase 41 trial
MK0826, ertapenem sodium / Duration of Treatment: 14 DaysPhase 31 trial
Imipenem, Cilastatin and RelebactamPhase 11 trial
Imipenem-relebactamPhase 11 trial
Active Trials
NCT04493151Completed8Est. Jun 2023
NCT04147221Completed9Est. Sep 2021
NCT00397956Completed30Est. Dec 2005
+1 more trials
Abbott
AbbottABBOTT PARK, IL
2 programs
1
Eicosapentaenoic acid, Gamma-Linolenic Acid and Antioxidant VitaminsPhase 41 trial
NEWS and Sepsis ScreeningN/A1 trial
Active Trials
NCT02189096Completed705Est. Jul 2015
NCT00329680Completed115Est. Oct 2009
GS
Gilead SciencesFOSTER CITY, CA
1 program
1
Amphotericine in liposomePhase 41 trial
Active Trials
NCT00697944Unknown30Est. Mar 2009
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
2 programs
1
Drotrecogin alfaPhase 31 trial
Follow-up Data of Patients Treated With XIGRIS® in FranceN/A1 trial
Active Trials
NCT00803231Completed1,004Est. Dec 2009
NCT00049764Completed474Est. Apr 2005
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
2 programs
1
Hydrocortisone administrationPhase 31 trial
Sepsis Characterization in KilimanjaroN/A1 trial
Active Trials
NCT05139459CompletedEst. Nov 2023
NCT07332325Not Yet RecruitingEst. Sep 2029
Fresenius Kabi
Fresenius KabiGermany - Bad Homburg
1 program
1
6 % Hydroxyethylstarch 130/0.4 = "Voluven®"Phase 31 trial
Active Trials
NCT00464204Completed196Est. Dec 2010
CytoSorbents
CytoSorbentsPRINCETON, NJ
1 program
1
CytoSorb hemoperfusionPhase 31 trial
Active Trials
NCT04643639Completed24Est. Oct 2022
Alliance Pharmaceuticals
1 program
1
NorepinephrinePhase 31 trial
Active Trials
NCT05179499Recruiting1,006Est. Oct 2027
HM
Huadong MedicineChina - Hangzhou
1 program
1
rhTPOPhase 2/31 trial
Active Trials
NCT02707497RecruitingEst. Sep 2024
AM-Pharma
AM-PharmaNetherlands - Utrecht
1 program
1
Alkaline PhosphatasePhase 21 trial
Active Trials
NCT00430859CompletedEst. Mar 2006
E
EisaiChina - Liaoning
1 program
1
E5564Phase 21 trial
Active Trials
NCT00046072Completed300Est. Apr 2005
GSK
GSKLONDON, United Kingdom
2 programs
2
SRT2379Phase 11 trial
SRT2379Phase 11 trial
Active Trials
NCT01262911Completed17Est. Apr 2011
NCT01416376Completed39Est. Dec 2011
Regeneron
RegeneronTARRYTOWN, NY
1 program
1
AlirocumabPhase 1Monoclonal Antibody1 trial
Active Trials
NCT05469347Completed50Est. Feb 2025
Novartis
NovartisBASEL, Switzerland
1 program
1
L-argininePhase 11 trial
Active Trials
NCT01775020Completed8Est. May 2012
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
1
OPT101Phase 11 trial
Active Trials
NCT06669403Not Yet RecruitingEst. May 2026
Genentech
GenentechCA - Oceanside
1 program
1
TNX-832Phase 11 trial
Active Trials
NCT01438853Completed18Est. Feb 2008
Bayer
BayerLEVERKUSEN, Germany
3 programs
Diagnosis of both VTE and sepsisN/A1 trial
Local standard medical careN/A1 trial
No study interventionN/A3 trials
Active Trials
NCT06765681Active Not Recruiting10,000Est. Mar 2026
NCT06986798Completed150Est. Feb 2026
NCT06949553Recruiting250Est. Feb 2029
+2 more trials
BlueJay Therapeutics
BlueJay TherapeuticsCA - Redwood City
2 programs
Multicenter Symphony IL-6 Monitoring Sepsis ICU StudyN/A1 trial
Symphony IL-6 Reference Range StudyN/A1 trial
Active Trials
NCT06181604CompletedEst. Jul 2024
NCT05048888UnknownEst. Mar 2024
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
2 programs
Next-Generation SequencingN/A1 trial
Standard diagnosticsN/A1 trial
Active Trials
NCT03356249Completed500Est. Sep 2021
NCT04571801Completed410Est. Apr 2024
Mission Therapeutics
Mission TherapeuticsUK - Cambridge
1 program
Antibiotics, VasopressorsN/A1 trial
Active Trials
NCT07171918Completed130Est. Dec 2024
Providence Therapeutics
1 program
CRPN/A1 trial
Active Trials
NCT03714841UnknownEst. May 2021
City Therapeutics
City TherapeuticsMA - Cambridge
1 program
Can Gdf-15 Level Predict Progression to Multiple Organ Failure in Patients With Septic ShockN/A1 trial
Active Trials
NCT06808100Enrolling By InvitationEst. Apr 2026
Pfizer
PfizerNEW YORK, NY
1 program
Linezolid or VancomycinN/A1 trial
Active Trials
NCT00811980Completed60Est. Jun 2010
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
Novolin RN/A1 trial
Active Trials
NCT00282594Completed317Est. Oct 2005
Hamilton medical
Hamilton medicalSwitzerland - Bonaduz
1 program
Procalcitonin-guided decision makingN/A1 trial
Active Trials
NCT00854932UnknownEst. Aug 2016

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Merck & Co.Imipenem
Gilead SciencesAmphotericine in liposome
AbbottEicosapentaenoic acid, Gamma-Linolenic Acid and Antioxidant Vitamins
Allergy TherapeuticsHydrocortisone administration
Alliance PharmaceuticalsNorepinephrine
CytoSorbentsCytoSorb hemoperfusion
Fresenius Kabi6 % Hydroxyethylstarch 130/0.4 = "Voluven®"
Merck & Co.MK0826, ertapenem sodium / Duration of Treatment: 14 Days
Eli Lilly and CompanyDrotrecogin alfa
Huadong MedicinerhTPO
AM-PharmaAlkaline Phosphatase
EisaiE5564
T-TherapeuticsOPT101
RegeneronAlirocumab
Merck & Co.Imipenem, Cilastatin and Relebactam

Showing 15 of 38 trials with date data

Clinical Trials (38)

Total enrollment: 22,364 patients across 38 trials

NCT02616354Merck & Co.Imipenem

Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin

Start: Jan 2015Est. completion: Dec 201524 patients
Phase 4Unknown
NCT00697944Gilead SciencesAmphotericine in liposome

Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

Start: Mar 2008Est. completion: Mar 200930 patients
Phase 4Unknown
NCT00329680AbbottEicosapentaenoic acid, Gamma-Linolenic Acid and Antioxidant Vitamins

The Effects of Eicosapentaenoic Acid (EPA), Gamma-Linolenic Acid (GLA) and Antioxidants in the Treatment of Sepsis

Start: Jun 2007Est. completion: Oct 2009115 patients
Phase 4Completed
NCT07332325Allergy TherapeuticsHydrocortisone administration

STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis

Start: Apr 2026Est. completion: Sep 2029
Phase 3Not Yet Recruiting
NCT05179499Alliance PharmaceuticalsNorepinephrine

Early Vasopressors in Sepsis

Start: Oct 2022Est. completion: Oct 20271,006 patients
Phase 3Recruiting
NCT04643639CytoSorbentsCytoSorb hemoperfusion

Assessing the Effects of CytoSorb Hemoperfusion on the Development on Immunoparalysis

Start: Sep 2020Est. completion: Oct 202224 patients
Phase 3Completed
NCT00464204Fresenius Kabi6 % Hydroxyethylstarch 130/0.4 = "Voluven®"

Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis

Start: Jul 2007Est. completion: Dec 2010196 patients
Phase 3Completed
NCT00397956Merck & Co.MK0826, ertapenem sodium / Duration of Treatment: 14 Days

To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)

Start: Sep 2004Est. completion: Dec 200530 patients
Phase 3Completed
NCT00049764Eli Lilly and CompanyDrotrecogin alfa

Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

Start: Nov 2002Est. completion: Apr 2005474 patients
Phase 3Completed
NCT02707497Huadong MedicinerhTPO

The Effect of REcombinant Human Thrombopoietin (rhTPO) on Sepsis Patients With aCUte Severe thrombocytopEnia

Start: Apr 2019Est. completion: Sep 2024
Phase 2/3Recruiting
NCT00430859AM-PharmaAlkaline Phosphatase

Bovine Intestinal Alkaline Phosphatase for the Treatment of Patients With Sepsis

Start: Sep 2004Est. completion: Mar 2006
Phase 2Completed
NCT00046072EisaiE5564

A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis

Start: Oct 2001Est. completion: Apr 2005300 patients
Phase 2Completed
NCT06669403T-TherapeuticsOPT101

OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis

Start: Dec 2025Est. completion: May 2026
Phase 1Not Yet Recruiting
NCT05469347RegeneronAlirocumab

Alirocumab in Patients with Sepsis

Start: Jan 2023Est. completion: Feb 202550 patients
Phase 1Completed
NCT04493151Merck & Co.Imipenem, Cilastatin and Relebactam

Imipenem/Cilastatin/Relebactam PK in ECMO

Start: Jan 2021Est. completion: Jun 20238 patients
Phase 1Completed
NCT04147221Merck & Co.Imipenem-relebactam

Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance

Start: Feb 2020Est. completion: Sep 20219 patients
Phase 1Completed
NCT01416376GSKSRT2379

Effect of Multiple Dose Levels of SRT2379 on Endotoxin-Induced Inflammation

Start: Aug 2011Est. completion: Dec 201139 patients
Phase 1Completed
NCT01262911GSKSRT2379

Effect of SRT2379 on Endotoxin-Induced Inflammation

Start: Feb 2011Est. completion: Apr 201117 patients
Phase 1Completed
NCT01438853GenentechTNX-832

Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome

Start: Dec 2004Est. completion: Feb 200818 patients
Phase 1Completed
NCT01775020NovartisL-arginine

Dose-response Study of Arginine Supplementation in Severe Sepsis

Start: Oct 2003Est. completion: May 20128 patients
Phase 1Completed
NCT06808100City TherapeuticsCan Gdf-15 Level Predict Progression to Multiple Organ Failure in Patients With Septic Shock

Can Gdf-15 Level Predict Progression to Multiple Organ Failure in Patients With Septic Shock

Start: May 2025Est. completion: Apr 2026
N/AEnrolling By Invitation
NCT06949553BayerNo study intervention

An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies

Start: Apr 2025Est. completion: Feb 2029250 patients
N/ARecruiting
NCT06986798BayerLocal standard medical care

A Study to Learn About the Occurrence of Disseminated Intravascular Coagulation in People With Sepsis and Further Worsening of Sepsis

Start: Jan 2025Est. completion: Feb 2026150 patients
N/ACompleted
NCT06765681BayerDiagnosis of both VTE and sepsis

An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related

Start: Jan 2025Est. completion: Mar 202610,000 patients
N/AActive Not Recruiting
NCT06728332BayerNo study intervention

An Observational Study to Learn More About How Menopause Affects Women's Sleep and How They Are Being Treated for Sleep Problems

Start: Dec 2024Est. completion: Oct 2025750 patients
N/ACompleted
NCT06373159BayerNo study intervention

An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan

Start: Mar 2024Est. completion: Nov 20255,740 patients
N/ACompleted
NCT06181604BlueJay TherapeuticsMulticenter Symphony IL-6 Monitoring Sepsis ICU Study

Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

Start: Jan 2024Est. completion: Jul 2024
N/ACompleted
NCT07171918Mission TherapeuticsAntibiotics, Vasopressors

Prospective Observational Study to Compare REMS vs NEWS2 for Patients Presenting to the ED With Sepsis

Start: Jan 2023Est. completion: Dec 2024130 patients
N/ACompleted
NCT04571801Heidelberg PharmaStandard diagnostics

Optimization of Sepsis Therapy Based on Patient-specific Digital Precision Diagnostics

Start: Mar 2022Est. completion: Apr 2024410 patients
N/ACompleted
NCT05139459Allergy TherapeuticsSepsis Characterization in Kilimanjaro

Sepsis Characterization in Kilimanjaro

Start: Jan 2022Est. completion: Nov 2023
N/ACompleted
NCT05048888BlueJay TherapeuticsSymphony IL-6 Reference Range Study

Symphony IL-6 Reference Range Study

Start: Aug 2021Est. completion: Mar 2024
N/AUnknown
NCT03356249Heidelberg PharmaNext-Generation Sequencing

Next-Generation Sequencing Diagnostics of Bacteremia in Sepsis

Start: Mar 2019Est. completion: Sep 2021500 patients
N/ACompleted
NCT03714841Providence TherapeuticsCRP

C-reactive Protein Information and Blood Cultures for Emergency Department Patients With Sepsis

Start: Jan 2017Est. completion: May 2021
N/AUnknown
NCT02189096AbbottNEWS and Sepsis Screening

Validation of Early Warning Score & Lactate in Prehospital Screening

Start: May 2014Est. completion: Jul 2015705 patients
N/ACompleted
NCT00854932Hamilton medicalProcalcitonin-guided decision making

Neonatal Procalcitonin Intervention Study

Start: Jun 2009Est. completion: Aug 2016
N/AUnknown
NCT00811980PfizerLinezolid or Vancomycin

The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents

Start: Jan 2009Est. completion: Jun 201060 patients
N/ACompleted
NCT00803231Eli Lilly and CompanyFollow-up Data of Patients Treated With XIGRIS® in France

Follow-up Data of Patients Treated With XIGRIS® in France

Start: Nov 2008Est. completion: Dec 20091,004 patients
N/ACompleted
NCT00282594Novo NordiskNovolin R

The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit

Start: Jul 2003Est. completion: Oct 2005317 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

6 late-stage (Phase 3) programs — potential near-term approvals
3 actively recruiting trials targeting 22,364 patients
26 companies competing in this space

Related Indications

HIV Infections(449)COVID-19(223)Hepatitis C(191)Influenza(173)HIV(138)HIV-1-infection(115)Hepatitis C, Chronic(94)Chronic Hepatitis B(93)Chronic Hepatitis C(91)Covid19(79)