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Drug Pipeline Review Therapy area: Hypercholesterolemia40–50 pages · PDF + Excel tracker

Hypercholesterolemia Drug Pipeline: 67 Assets by Phase

Hypercholesterolemia pipeline: 67 drug candidates in clinical development, 24 in Phase III, from 35 sponsors. Data as of 3 Oct 2026.

Pipeline Terminal Hypercholesterolemia Data as of 3 Oct 2026
Candidates in development 67assets Desk-reviewed How this number is madeEvery drug named in an interventional trial, merged across code, generic and brand names, with a live or recent industry trial. Placebo and comparator arms excluded.
Phase III 2436% of pipeline Registry How this number is madeCandidates whose highest phase in a live or recent trial is Phase III (Phase II/III counts as Phase II).
Phase II 1116% of pipeline Registry
Phase I 3248% of pipeline Registry
Sponsors 35top 5 hold 42% Registry How this number is madeCompanies credited with at least one candidate: the lead sponsor on most of that candidate's industry trials.
Registered trials 424108 running Registry How this number is madeInterventional trials on ClinicalTrials.gov for the conditions in scope, updated since 3 Oct 2021.
Readouts in 12 months 8Phase II or later Sponsor dates How this number is madeCandidates with a registered primary completion date in the next 12 months. Dates are the sponsor's own and often move.
Trials with US sites 12229% · Europe 21% Registry How this number is madeTrials with at least one site in the United States; Europe is the EU/EEA, the UK and Switzerland. A trial counts in every region where it has a site.

Candidates by highest phase reached

Phase I32
Phase II11
Phase III24

Next registered primary completions, Phase II or later

CandidatePhasePrimary completion
EDP167Phase IIOct 2026 (est.)
LaroprovstatPhase IIIJan 2027 (est.)
DII235Phase IIApr 2027 (est.)

Candidates in development by lead sponsor

AstraZeneca13
Addpharma Inc.5
Boryung Pharmaceutical Co., Ltd4
Novartis Pharmaceuticals3
Verve Therapeutics, Inc.3

Phase II and III primary completions per quarter

Q4 20261
Q1 20271
Q2 20275
Q3 20271
Q4 20275
Q1 20280
Q2 20280
Q3 20283

Answers at a glance

  • 24 of 67 hypercholesterolemia candidates (36%) are in Phase III.
  • AstraZeneca runs the largest hypercholesterolemia pipeline, with 13 candidates.
  • 8 readouts are due in 12 months; the next is EDP167 in Oct 2026.
  • 49 trials are recruiting patients now; 29% of all trials have a US site and 21% a European one.
67 candidates424 trials69 countriesData as of 3 Oct 2026Next refresh by 1 Jan 2027
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Edition: data as of 3 Oct 2026 Next refresh: by 1 Jan 2027 Change: Since 3 Oct 2026: assets +1, Phase III 0, trials 0

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A sample of the Hypercholesterolemia Pipeline Review: the full chapter list, the tracker columns and two asset profiles from the report. The Research Desk reviews your request and emails it, usually within one business day.

Hypercholesterolemia has 67 drug candidates in active clinical development, of which 24 are in Phase III, 11 in Phase II and 32 in Phase I, according to Douglas Insights' count of 424 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).

The hypercholesterolemia 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 hypercholesterolemia drugs are in each phase of development?

Douglas Insights counts 24 hypercholesterolemia candidates in Phase III, 36% of the 67 assets in development; Phase II holds 11 and Phase I holds 32.

Phase I32Phase II11Phase III24
Candidates by highest phase reached. Source: Douglas Insights from ClinicalTrials.gov, data as of 3 Oct 2026.
Phase (highest reached)AssetsShare of pipeline
Phase III2436%
Phase II1116%
Phase I3248%
Total67100%

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each hypercholesterolemia asset appears in exactly one row. The 108 trials still recruiting or running carry 25% of the 424 registered trials in scope.

Which approved hypercholesterolemia medicines are still in trials?

5 medicines already on the market are still being tested in hypercholesterolemia Phase IV trials; Ezetimibe has the most, with 82 registered trials.

MedicineLead sponsorRegistered trials
EzetimibeOrganon and Co82
InclisiranNovartis Pharmaceuticals31
EvolocumabAmgen30
Bempedoic acidSeveral sponsors13
AlirocumabSanofi7

Post-approval hypercholesterolemia 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 hypercholesterolemia trials are recruiting patients now?

49 hypercholesterolemia trials are recruiting patients and 33 more have not started recruiting yet, out of 424 interventional trials in scope; together they make up 19% of the trial base.

Registry statusTrialsShare
Completed28467%
Recruiting4912%
Not yet recruiting337.8%
Active, not recruiting204.7%
Status not verified184.2%
Terminated102.4%
Enrolling by invitation61.4%
Withdrawn30.7%
Suspended10.2%

Terminated, suspended and withdrawn hypercholesterolemia 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 hypercholesterolemia pipeline?

AstraZeneca leads the hypercholesterolemia pipeline with 13 candidates; the top 5 sponsors hold 42% of the 67 assets, and 35 sponsors run at least one.

SponsorAssets in developmentShare
AstraZeneca1319%
Addpharma Inc.57.5%
Boryung Pharmaceutical Co., Ltd46.0%
Novartis Pharmaceuticals34.5%
Verve Therapeutics, Inc.34.5%

Industry sponsors lead 338 of the 424 hypercholesterolemia trials (80%); 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 hypercholesterolemia pipeline?

Mechanism and drug-type classification for the 67 hypercholesterolemia 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 hypercholesterolemia trial readouts are coming next?

8 hypercholesterolemia 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.

CandidateSponsorPhasePrimary completionRegistry
EDP167Eddingpharm (Zhuhai) Co., Ltd.Phase IIOct 2026 (estimated)NCT07489209
LaroprovstatAstraZenecaPhase IIIJan 2027 (estimated)NCT07000136
DII235Novartis PharmaceuticalsPhase IIApr 2027 (estimated)NCT07235046

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 hypercholesterolemia readouts fall in each quarter?

16 hypercholesterolemia candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 5, due in Q2 2027.

QuarterPhase III readoutsPhase II readoutsTotal
Q4 2026011
Q1 2027101
Q2 2027145
Q3 2027101
Q4 2027415
Q1 2028000
Q2 2028000
Q3 2028213

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 hypercholesterolemia trials?

United States hosts the most hypercholesterolemia trials, with sites in 122 of the 424 studies (29%); trials in scope run in 69 countries in all.

CountryTrials with a siteShare of trials
United States12229%
China9923%
Canada5112%
South Korea4511%
Australia419.7%
Spain399.2%
Germany368.5%
Netherlands368.5%

A multinational hypercholesterolemia 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 hypercholesterolemia drugs being tested?

122 of the 424 hypercholesterolemia trials (29%) have a site in the United States, 87 (21%) in Europe and 99 (23%) in China; 26 of the 67 candidates in development are tested in the US.

RegionTrials with a siteShare of trialsCandidates testedRegulator
United States12229%26FDA
Europe (EU/EEA, UK, Switzerland)8721%12EMA, MHRA, Swissmedic
China9923%22NMPA
Japan276.4%5PMDA
Rest of world14935%31national 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 hypercholesterolemia 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 hypercholesterolemia pipeline since the last update?

Since 3 Oct 2026, the hypercholesterolemia pipeline count moved by +1 assets to 67, Phase III moved by 0 and the trial base by 0.

How does Douglas Insights count the hypercholesterolemia pipeline?

Douglas Insights read 424 interventional trials registered on ClinicalTrials.gov for the conditions "hypercholesterolemia", "hyperlipoproteinemia(a)" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 67 unique candidates.

  1. 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.
  2. 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.
  3. Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
  4. 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 Hypercholesterolemia Pipeline Review include?

The Hypercholesterolemia Pipeline Review covers all 67 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.

11 chapters40–50 pages25 asset profilesExcel tracker of all 67 candidates
01Executive summary and our call2–3 pp

The pipeline on one page and the desk's verdict on where hypercholesterolemia 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 hypercholesterolemia 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 hypercholesterolemia, 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 Hypercholesterolemia review

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Frequently asked questions about the hypercholesterolemia pipeline

How many drugs are in the hypercholesterolemia pipeline?

67 drug candidates are in active clinical development for hypercholesterolemia, with 24 in Phase III, per Douglas Insights (data as of 3 Oct 2026).

Which company has the most hypercholesterolemia drugs in development?

13 candidates make AstraZeneca the largest hypercholesterolemia pipeline sponsor, out of 35 sponsors counted by Douglas Insights.

When is the next hypercholesterolemia trial readout?

Oct 2026 is the registered primary completion of the Phase II trial of EDP167 (NCT07489209), the next hypercholesterolemia catalyst in Douglas Insights' calendar.

How many hypercholesterolemia trials run in the United States and Europe?

122 hypercholesterolemia trials have a US site and 87 a European site, out of 424 registered trials counted by Douglas Insights (data as of 3 Oct 2026).

How often is the hypercholesterolemia 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.

Cite this page Douglas Insights (2026). Hypercholesterolemia Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/hypercholesterolemia/