Heart Failure has 94 drug candidates in active clinical development, of which 16 are in Phase III, 38 in Phase II and 40 in Phase I, according to Douglas Insights' count of 948 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).
The heart failure 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 heart failure drugs are in each phase of development?
Douglas Insights counts 16 heart failure candidates in Phase III, 17% of the 94 assets in development; Phase II holds 38 and Phase I holds 40.
| Phase (highest reached) | Assets | Share of pipeline |
|---|---|---|
| Phase III | 16 | 17% |
| Phase II | 38 | 40% |
| Phase I | 40 | 43% |
| Total | 94 | 100% |
Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each heart failure asset appears in exactly one row. The 353 trials still recruiting or running carry 37% of the 948 registered trials in scope.
Which approved heart failure medicines are still in trials?
6 medicines already on the market are still being tested in heart failure Phase IV trials; Dapagliflozin has the most, with 56 registered trials.
| Medicine | Lead sponsor | Registered trials |
|---|---|---|
| Dapagliflozin | AstraZeneca | 56 |
| Sacubitril/valsartan | Novartis Pharmaceuticals | 55 |
| Finerenone | Bayer | 19 |
| Vericiguat | Bayer | 16 |
| Ferric carboxymaltose | American Regent, Inc. | 9 |
| Sotagliflozin | Lexicon Pharmaceuticals | 8 |
Post-approval heart failure 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 heart failure trials are recruiting patients now?
209 heart failure trials are recruiting patients and 80 more have not started recruiting yet, out of 948 interventional trials in scope; together they make up 30% of the trial base.
| Registry status | Trials | Share |
|---|---|---|
| Completed | 378 | 40% |
| Recruiting | 209 | 22% |
| Status not verified | 100 | 11% |
| Not yet recruiting | 80 | 8.4% |
| Terminated | 70 | 7.4% |
| Active, not recruiting | 52 | 5.5% |
| Withdrawn | 42 | 4.4% |
| Enrolling by invitation | 12 | 1.3% |
| Suspended | 5 | 0.5% |
Terminated, suspended and withdrawn heart failure 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 heart failure pipeline?
AstraZeneca leads the heart failure pipeline with 8 candidates; the top 5 sponsors hold 32% of the 94 assets, and 56 sponsors run at least one.
| Sponsor | Assets in development | Share |
|---|---|---|
| AstraZeneca | 8 | 8.5% |
| HELP Therapeutics Co., Ltd. | 7 | 7.4% |
| Tasly Pharmaceutical Group Co., Ltd | 6 | 6.4% |
| Novo Nordisk A/S | 5 | 5.3% |
| Fujian Shengdi Pharmaceutical Co., Ltd. | 4 | 4.3% |
Industry sponsors lead 279 of the 948 heart failure trials (29%); 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 heart failure pipeline?
Mechanism and drug-type classification for the 94 heart failure 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 heart failure trial readouts are coming next?
14 heart failure 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 |
|---|---|---|---|---|
| Levosimendan | Tenax Therapeutics, Inc. | Phase II/III | Oct 2026 (estimated) | NCT07262723 |
| AB-1002 | AskBio Inc | Phase II | Oct 2026 (estimated) | NCT05598333 |
| JK07 | Salubris Biotherapeutics Inc | Phase II | Oct 2026 (estimated) | NCT06369298 |
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 heart failure readouts fall in each quarter?
23 heart failure candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 8, due in Q4 2026.
| Quarter | Phase III readouts | Phase II readouts | Total |
|---|---|---|---|
| Q4 2026 | 1 | 7 | 8 |
| Q1 2027 | 0 | 1 | 1 |
| Q2 2027 | 2 | 2 | 4 |
| Q3 2027 | 1 | 0 | 1 |
| Q4 2027 | 0 | 2 | 2 |
| Q1 2028 | 0 | 1 | 1 |
| Q2 2028 | 3 | 0 | 3 |
| Q3 2028 | 0 | 3 | 3 |
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 heart failure trials?
United States hosts the most heart failure trials, with sites in 375 of the 948 studies (40%); trials in scope run in 81 countries in all.
| Country | Trials with a site | Share of trials |
|---|---|---|
| United States | 375 | 40% |
| China | 131 | 14% |
| Canada | 111 | 12% |
| Poland | 103 | 11% |
| Germany | 101 | 11% |
| United Kingdom | 94 | 9.9% |
| Spain | 93 | 9.8% |
| Italy | 79 | 8.3% |
A multinational heart failure 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 heart failure drugs being tested?
375 of the 948 heart failure trials (40%) have a site in the United States, 322 (34%) in Europe and 131 (14%) in China; 47 of the 94 candidates in development are tested in the US.
| Region | Trials with a site | Share of trials | Candidates tested | Regulator |
|---|---|---|---|---|
| United States | 375 | 40% | 47 | FDA |
| Europe (EU/EEA, UK, Switzerland) | 322 | 34% | 35 | EMA, MHRA, Swissmedic |
| China | 131 | 14% | 43 | NMPA |
| Japan | 47 | 5.0% | 19 | PMDA |
| Rest of world | 291 | 31% | 37 | 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 heart failure 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 heart failure pipeline since the last update?
Since 3 Oct 2026, the heart failure pipeline count moved by +1 assets to 94, Phase III moved by 0 and the trial base by 0.
How does Douglas Insights count the heart failure pipeline?
Douglas Insights read 948 interventional trials registered on ClinicalTrials.gov for the conditions "heart failure" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 94 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 Heart Failure Pipeline Review include?
The Heart Failure Pipeline Review covers all 94 candidates in an Excel tracker and profiles the leading 25 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 heart failure 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 heart failure 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 heart failure, 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 Heart Failure 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 heart failure pipeline
How many drugs are in the heart failure pipeline?
94 drug candidates are in active clinical development for heart failure, with 16 in Phase III, per Douglas Insights (data as of 3 Oct 2026).
Which company has the most heart failure drugs in development?
8 candidates make AstraZeneca the largest heart failure pipeline sponsor, out of 56 sponsors counted by Douglas Insights.
When is the next heart failure trial readout?
Oct 2026 is the registered primary completion of the Phase II/III trial of Levosimendan (NCT07262723), the next heart failure catalyst in Douglas Insights' calendar.
How many heart failure trials run in the United States and Europe?
375 heart failure trials have a US site and 322 a European site, out of 948 registered trials counted by Douglas Insights (data as of 3 Oct 2026).
How often is the heart failure pipeline count updated?
90 days is the refresh cycle; this edition uses registry data as of 3 Oct 2026 and the next is due by 1 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). Heart Failure Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/heart-failure/