Sepsis has 21 drug candidates in active clinical development, of which 5 are in Phase III, 8 in Phase II and 8 in Phase I, according to Douglas Insights' count of 541 interventional trials registered on ClinicalTrials.gov (data as of 4 Oct 2026).
The sepsis drug pipeline is the set of medicines that sponsors are still testing in people for this condition: each candidate is counted once, at the highest phase it has reached in a running or recently completed trial. Medicines already on the market and studied only in Phase IV trials are kept out of the count.
How many sepsis drugs are in each phase of development?
Douglas Insights counts 5 sepsis candidates in Phase III, 24% of the 21 assets in development; Phase II holds 8 and Phase I holds 8.
| Phase (highest reached) | Assets | Share of pipeline |
|---|---|---|
| Phase III | 5 | 24% |
| Phase II | 8 | 38% |
| Phase I | 8 | 38% |
| Total | 21 | 100% |
Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each sepsis asset appears in exactly one row. The 184 trials still recruiting or running carry 34% of the 541 registered trials in scope.
Which approved sepsis medicines are still in trials?
1 medicines already on the market are still being tested in sepsis Phase IV trials; Catheter lock has the most, with 2 registered trials.
| Medicine | Lead sponsor | Registered trials |
|---|---|---|
| Catheter lock | CorMedix Therapeutics | 2 |
Post-approval sepsis trials test new doses, new patient groups and head-to-head comparisons. They set the standard of care that every candidate in development will be measured against, so the paid review profiles each one.
How many sepsis trials are recruiting patients now?
106 sepsis trials are recruiting patients and 60 more have not started recruiting yet, out of 541 interventional trials in scope; together they make up 31% of the trial base.
| Registry status | Trials | Share |
|---|---|---|
| Completed | 223 | 41% |
| Recruiting | 106 | 20% |
| Status not verified | 72 | 13% |
| Not yet recruiting | 60 | 11% |
| Terminated | 41 | 7.6% |
| Withdrawn | 18 | 3.3% |
| Active, not recruiting | 15 | 2.8% |
| Suspended | 3 | 0.6% |
| Enrolling by invitation | 3 | 0.6% |
Terminated, suspended and withdrawn sepsis trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as in development.
Which companies lead the sepsis pipeline?
AstraZeneca leads the sepsis pipeline with 2 candidates; the top 5 sponsors hold 38% of the 21 assets, and 18 sponsors run at least one.
| Sponsor | Assets in development | Share |
|---|---|---|
| AstraZeneca | 2 | 9.5% |
| Basilea Pharmaceutica | 2 | 9.5% |
| PT. Prodia Stem Cell Indonesia | 2 | 9.5% |
| Armata Pharmaceuticals, Inc. | 1 | 4.8% |
| Artcline GmbH | 1 | 4.8% |
Industry sponsors lead 74 of the 541 sepsis trials (14%); universities, hospitals and public funders lead the rest. A sponsor is credited with an asset when it is the lead sponsor on most of that asset's industry trials.
Which drug types and mechanisms dominate the sepsis pipeline?
Mechanism and drug-type classification for the 21 sepsis candidates is done by the research desk asset by asset, each with a cited source, and is published in the paid review together with the white-space map.
What sepsis trial readouts are coming next?
4 sepsis candidates in Phase II or later have a registered primary completion date in the next 12 months; the next three are below, each linked to its registry record.
| Candidate | Sponsor | Phase | Primary completion | Registry |
|---|---|---|---|---|
| Pralurbactam | Qilu Pharmaceutical Co., Ltd. | Phase III | Dec 2026 (estimated) | NCT07089186 |
| YD0743 | Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. | Phase II | Dec 2026 (estimated) | NCT07413094 |
| AZD4144 | AstraZeneca | Phase II | Feb 2027 (estimated) | NCT07215702 |
Primary completion is the date a sponsor expects the last patient to finish the main measurement, so data usually follow within months. Dates marked estimated are the sponsor's own forecast on the registry and often move.
How many sepsis readouts fall in each quarter?
6 sepsis candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 2, due in Q4 2026.
| Quarter | Phase III readouts | Phase II readouts | Total |
|---|---|---|---|
| Q4 2026 | 1 | 1 | 2 |
| Q1 2027 | 0 | 1 | 1 |
| Q2 2027 | 0 | 0 | 0 |
| Q3 2027 | 0 | 1 | 1 |
| Q4 2027 | 0 | 0 | 0 |
| Q1 2028 | 1 | 1 | 2 |
| Q2 2028 | 0 | 0 | 0 |
| Q3 2028 | 0 | 0 | 0 |
Each candidate is counted once, at its next readout. The paid catalyst calendar names every readout with its trial, sponsor and design, adds filings and regulatory decisions, and runs 24 months ahead.
Which countries host the most sepsis trials?
United States hosts the most sepsis trials, with sites in 125 of the 541 studies (23%); trials in scope run in 84 countries in all.
| Country | Trials with a site | Share of trials |
|---|---|---|
| United States | 125 | 23% |
| France | 72 | 13% |
| China | 70 | 13% |
| Egypt | 41 | 7.6% |
| Spain | 28 | 5.2% |
| Canada | 28 | 5.2% |
| Germany | 26 | 4.8% |
| Belgium | 21 | 3.9% |
A multinational sepsis trial is counted once in every country where it has a site, so the shares add up to more than 100%. Country spread shows where sponsors are building the evidence that regulators in each market will ask for.
Where are sepsis drugs being tested?
125 of the 541 sepsis trials (23%) have a site in the United States, 167 (31%) in Europe and 70 (13%) in China; 11 of the 21 candidates in development are tested in the US.
| Region | Trials with a site | Share of trials | Candidates tested | Regulator |
|---|---|---|---|---|
| United States | 125 | 23% | 11 | FDA |
| Europe (EU/EEA, UK, Switzerland) | 167 | 31% | 10 | EMA, MHRA, Swissmedic |
| China | 70 | 13% | 5 | NMPA |
| Japan | 8 | 1.5% | 3 | PMDA |
| Rest of world | 190 | 35% | 9 | national regulators |
Each region's trials are the evidence its regulator will review: the FDA in the United States, the EMA (with the MHRA and Swissmedic) in Europe, the NMPA in China and the PMDA in Japan. A multinational sepsis trial counts once in every region where it has a site, so the shares add up to more than 100%. A candidate tested only outside the US and Europe is often a licensing opportunity for sponsors in those markets.
What has changed in the sepsis pipeline since the last update?
This is the first edition of the sepsis pipeline count, dated 4 Oct 2026. The next refresh is due by 2 Jan 2027, and each refresh lists the assets that entered, advanced or dropped out.
How does Douglas Insights count the sepsis pipeline?
Douglas Insights read 541 interventional trials registered on ClinicalTrials.gov for the conditions "sepsis", "septic shock" and updated since 4 Oct 2021, then grouped every drug or biologic named in them into 21 unique candidates.
- Code names, generic names and brand names of the same molecule are merged into one candidate, and every merge is reviewed by the research desk.
- A candidate counts when it has a trial that is recruiting, running, or completed in the last 24 months, and at least one industry-sponsored trial.
- Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
- Each figure on this page is drawn from one frozen dataset that passes ten checks before release, and the owner approves every edition.
Read the full approach on the research methodology page, or browse other Pharmaceuticals research.
What does the Sepsis Pipeline Review include?
The Sepsis Pipeline Review covers all 21 candidates in an Excel tracker and profiles the leading 21 in a 40–50 page report, ending with the research desk's ranked view of the candidates most likely to win.
01Executive summary and our call2–3 pp
The pipeline on one page and the desk's verdict on where sepsis treatment is heading.
- Pipeline size and phase mix
- The three calls that matter
- What changed since the last edition
02Disease and unmet need3 pp
Who is treated today, what current therapy leaves unmet, and how regulators judge new medicines.
- Patient population and diagnosis
- Treatment guidelines and gaps
- Regulatory endpoints
03Approved therapies3 pp
The marketed medicines every sepsis candidate will be measured against.
- Marketed medicines and their sponsors
- Post-approval trials
- The bar a new entrant must clear
04Pipeline at a glance4 pp
Every candidate counted by phase, drug type, sponsor and country.
- Assets by phase and drug type
- Sponsors by size of pipeline
- Trial footprint: US, Europe, China, Japan
05Mechanism landscape and white space5 pp
Which mechanisms are crowded and which no sponsor has entered.
- Mechanism classes and crowding
- Classes with no candidate yet
- Differentiation by route and dosing
06Key asset profiles12–15 pp
The leading 25 candidates, one profile each, every claim linked to a source document.
- Design and endpoints of the pivotal trials
- Data to date, with sources
- Next readout and the risk to it
07Catalyst calendar3 pp
Readouts, filings and regulatory decisions 24 months ahead.
- Readouts by quarter
- Filings and regulatory decisions
- Date confidence for each event
08Deals and partnering3 pp
Who is licensing, buying and partnering in sepsis, and on what terms.
- Licensing and M&A in the area
- Deal terms where disclosed
- Sponsors open to partnering
09Sponsor landscape3 pp
Large pharma against biotech, and how concentrated the pipeline is.
- Pipeline share by sponsor
- Sponsor-by-phase matrix
- New entrants since the last edition
10Our call: winners, risks, opportunities3–4 pp
The candidates most likely to win, ranked, with the reasoning and evidence.
- Ranked candidates
- Risks that could change the order
- Openings for new entrants and investors
11Methodology and source log2 pp
How the count is built and every document behind it.
- How candidates are counted and merged
- Every source document listed
- The ten quality checks
Ways to buy the Sepsis review
| Option | What you get | Delivery | Price | |
|---|---|---|---|---|
| Pipeline Snapshot | This therapy area as published: PDF report + Excel tracker | Ready now | USD 3,000 | Enquire |
| Pipeline Review | Your indication, geography and phase cut-off; ranked calls and an analyst call | 2–3 weeks | From USD 4,000 | Enquire |
| Company Assessment | One sponsor's full pipeline against its peers | 2 weeks | From USD 5,000 | Enquire |
Frequently asked questions about the sepsis pipeline
How many drugs are in the sepsis pipeline?
21 drug candidates are in active clinical development for sepsis, with 5 in Phase III, per Douglas Insights (data as of 4 Oct 2026).
Which company has the most sepsis drugs in development?
2 candidates make AstraZeneca the largest sepsis pipeline sponsor, out of 18 sponsors counted by Douglas Insights.
When is the next sepsis trial readout?
Dec 2026 is the registered primary completion of the Phase III trial of Pralurbactam (NCT07089186), the next sepsis catalyst in Douglas Insights' calendar.
How many sepsis trials run in the United States and Europe?
125 sepsis trials have a US site and 167 a European site, out of 541 registered trials counted by Douglas Insights (data as of 4 Oct 2026).
How often is the sepsis pipeline count updated?
90 days is the refresh cycle; this edition uses registry data as of 4 Oct 2026 and the next is due by 2 Jan 2027.
Research & citation
This review was researched, written and reviewed by the Douglas Insights Research Desk under the Douglas Insights editorial standards. Material errors are logged in the corrections log. No section is sponsored.
Douglas Insights (2026). Sepsis Drug Pipeline, data as of 4 Oct 2026. https://www.douglasinsights.com/pipeline/sepsis/