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Drug Pipeline Review Therapy area: Obstructive Sleep Apnea40–50 pages · PDF + Excel tracker

Obstructive Sleep Apnea Drug Pipeline: 18 Assets by Phase

Obstructive Sleep Apnea pipeline: 18 drug candidates in clinical development, 13 in Phase III, from 14 sponsors. Data as of 4 Oct 2026.

Pipeline Terminal Obstructive Sleep Apnea Data as of 4 Oct 2026
Candidates in development 18assets 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 1372% 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 528% of pipeline Registry
Phase I 00.0% of pipeline Registry
Sponsors 14top 5 hold 50% 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 17264 running Registry How this number is madeInterventional trials on ClinicalTrials.gov for the conditions in scope, updated since 4 Oct 2021.
Readouts in 12 months 6Phase 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 9153% · Europe 16% 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 I0
Phase II5
Phase III13

Next registered primary completions, Phase II or later

CandidatePhasePrimary completion
HRS9531Phase IIIDec 2026 (est.)
SASS-001Phase IIDec 2026 (est.)
SivopixantPhase IIDec 2026 (est.)

Candidates in development by lead sponsor

Eli Lilly and Company4
Shionogi2
Apnimed1
Pfizer1
Gan & Lee Pharmaceuticals.1

Phase II and III primary completions per quarter

Q4 20263
Q1 20270
Q2 20272
Q3 20271
Q4 20272
Q1 20282
Q2 20282
Q3 20281

Answers at a glance

  • 13 of 18 obstructive sleep apnea candidates (72%) are in Phase III.
  • Eli Lilly and Company runs the largest obstructive sleep apnea pipeline, with 4 candidates.
  • 6 readouts are due in 12 months; the next is HRS9531 in Dec 2026.
  • 40 trials are recruiting patients now; 53% of all trials have a US site and 16% a European one.
18 candidates172 trials35 countriesData as of 4 Oct 2026Next refresh by 2 Jan 2027
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Edition: data as of 4 Oct 2026 Next refresh: by 2 Jan 2027 Change: First edition

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Obstructive Sleep Apnea has 18 drug candidates in active clinical development, of which 13 are in Phase III, 5 in Phase II and 0 in Phase I, according to Douglas Insights' count of 172 interventional trials registered on ClinicalTrials.gov (data as of 4 Oct 2026).

The obstructive sleep apnea 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 obstructive sleep apnea drugs are in each phase of development?

Douglas Insights counts 13 obstructive sleep apnea candidates in Phase III, 72% of the 18 assets in development; Phase II holds 5 and Phase I holds 0.

Phase I0Phase II5Phase III13
Candidates by highest phase reached. Source: Douglas Insights from ClinicalTrials.gov, data as of 4 Oct 2026.
Phase (highest reached)AssetsShare of pipeline
Phase III1372%
Phase II528%
Phase I00.0%
Total18100%

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each obstructive sleep apnea asset appears in exactly one row. The 64 trials still recruiting or running carry 37% of the 172 registered trials in scope.

How many obstructive sleep apnea trials are recruiting patients now?

40 obstructive sleep apnea trials are recruiting patients and 16 more have not started recruiting yet, out of 172 interventional trials in scope; together they make up 33% of the trial base.

Registry statusTrialsShare
Completed8851%
Recruiting4023%
Not yet recruiting169.3%
Status not verified127.0%
Active, not recruiting63.5%
Terminated52.9%
Withdrawn31.7%
Enrolling by invitation21.2%

Terminated, suspended and withdrawn obstructive sleep apnea 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 obstructive sleep apnea pipeline?

Eli Lilly and Company leads the obstructive sleep apnea pipeline with 4 candidates; the top 5 sponsors hold 50% of the 18 assets, and 14 sponsors run at least one.

SponsorAssets in developmentShare
Eli Lilly and Company422%
Shionogi211%
Apnimed15.6%
Pfizer15.6%
Gan & Lee Pharmaceuticals.15.6%

Industry sponsors lead 56 of the 172 obstructive sleep apnea trials (33%); 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 obstructive sleep apnea pipeline?

Mechanism and drug-type classification for the 18 obstructive sleep apnea 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 obstructive sleep apnea trial readouts are coming next?

6 obstructive sleep apnea 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
HRS9531Fujian Shengdi Pharmaceutical Co., Ltd.Phase IIIDec 2026 (estimated)NCT06974851
SASS-001ShionogiPhase IIDec 2026 (estimated)NCT06776432
SivopixantShionogiPhase IIDec 2026 (estimated)NCT06776432

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 obstructive sleep apnea readouts fall in each quarter?

13 obstructive sleep apnea candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 3, due in Q4 2026.

QuarterPhase III readoutsPhase II readoutsTotal
Q4 2026123
Q1 2027000
Q2 2027112
Q3 2027101
Q4 2027202
Q1 2028202
Q2 2028202
Q3 2028101

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 obstructive sleep apnea trials?

United States hosts the most obstructive sleep apnea trials, with sites in 91 of the 172 studies (53%); trials in scope run in 35 countries in all.

CountryTrials with a siteShare of trials
United States9153%
China2313%
Australia1911%
Canada148.1%
Spain105.8%
Taiwan105.8%
Germany95.2%
Brazil95.2%

A multinational obstructive sleep apnea 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 obstructive sleep apnea drugs being tested?

91 of the 172 obstructive sleep apnea trials (53%) have a site in the United States, 28 (16%) in Europe and 23 (13%) in China; 12 of the 18 candidates in development are tested in the US.

RegionTrials with a siteShare of trialsCandidates testedRegulator
United States9153%12FDA
Europe (EU/EEA, UK, Switzerland)2816%6EMA, MHRA, Swissmedic
China2313%9NMPA
Japan84.7%5PMDA
Rest of world4928%8national 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 obstructive sleep apnea 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 obstructive sleep apnea pipeline since the last update?

This is the first edition of the obstructive sleep apnea 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 obstructive sleep apnea pipeline?

Douglas Insights read 172 interventional trials registered on ClinicalTrials.gov for the conditions "Sleep Apnea, Obstructive", "obstructive sleep apnea" and updated since 4 Oct 2021, then grouped every drug or biologic named in them into 18 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 Obstructive Sleep Apnea Pipeline Review include?

The Obstructive Sleep Apnea Pipeline Review covers all 18 candidates in an Excel tracker and profiles the leading 18 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 18 candidates
01Executive summary and our call2–3 pp

The pipeline on one page and the desk's verdict on where obstructive sleep apnea 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 obstructive sleep apnea 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 obstructive sleep apnea, 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 Obstructive Sleep Apnea review

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Frequently asked questions about the obstructive sleep apnea pipeline

How many drugs are in the obstructive sleep apnea pipeline?

18 drug candidates are in active clinical development for obstructive sleep apnea, with 13 in Phase III, per Douglas Insights (data as of 4 Oct 2026).

Which company has the most obstructive sleep apnea drugs in development?

4 candidates make Eli Lilly and Company the largest obstructive sleep apnea pipeline sponsor, out of 14 sponsors counted by Douglas Insights.

When is the next obstructive sleep apnea trial readout?

Dec 2026 is the registered primary completion of the Phase III trial of HRS9531 (NCT06974851), the next obstructive sleep apnea catalyst in Douglas Insights' calendar.

How many obstructive sleep apnea trials run in the United States and Europe?

91 obstructive sleep apnea trials have a US site and 28 a European site, out of 172 registered trials counted by Douglas Insights (data as of 4 Oct 2026).

How often is the obstructive sleep apnea 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.

Cite this page Douglas Insights (2026). Obstructive Sleep Apnea Drug Pipeline, data as of 4 Oct 2026. https://www.douglasinsights.com/pipeline/obstructive-sleep-apnea/