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Drug Pipeline Review Therapy area: RSV40–50 pages · PDF + Excel tracker

RSV Drug Pipeline: 48 Assets by Phase

RSV pipeline: 48 drug candidates in clinical development, 7 in Phase III, from 22 sponsors. Data as of 3 Oct 2026.

Pipeline Terminal RSV Data as of 3 Oct 2026
Candidates in development 48assets 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 715% 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 817% of pipeline Registry
Phase I 3369% of pipeline Registry
Sponsors 22top 5 hold 63% 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 15638 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 5Phase 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 7951% · Europe 40% 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 I33
Phase II8
Phase III7

Next registered primary completions, Phase II or later

CandidatePhasePrimary completion
ZelicapavirPhase IIDec 2026 (est.)
S-337395Phase IIDec 2026 (est.)
RSVPreF3 OAPhase IIJan 2027 (est.)

Candidates in development by lead sponsor

Sanofi Pasteur, a Sanofi Company12
Guangzhou Patronus Biotech Co., Ltd.6
Sanofi5
GlaxoSmithKline4
Clover Biopharmaceuticals AUS Pty3

Phase II and III primary completions per quarter

Q4 20262
Q1 20271
Q2 20271
Q3 20271
Q4 20271
Q1 20281
Q2 20280
Q3 20280

Answers at a glance

  • 7 of 48 RSV candidates (15%) are in Phase III.
  • Sanofi Pasteur, a Sanofi Company runs the largest RSV pipeline, with 12 candidates.
  • 5 readouts are due in 12 months; the next is Zelicapavir in Dec 2026.
  • 21 trials are recruiting patients now; 51% of all trials have a US site and 40% a European one.
48 candidates156 trials57 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: First edition

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RSV has 48 drug candidates in active clinical development, of which 7 are in Phase III, 8 in Phase II and 33 in Phase I, according to Douglas Insights' count of 156 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).

The RSV 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 RSV drugs are in each phase of development?

Douglas Insights counts 7 RSV candidates in Phase III, 15% of the 48 assets in development; Phase II holds 8 and Phase I holds 33.

Phase I33Phase II8Phase III7
Candidates by highest phase reached. Source: Douglas Insights from ClinicalTrials.gov, data as of 3 Oct 2026.
Phase (highest reached)AssetsShare of pipeline
Phase III715%
Phase II817%
Phase I3369%
Total48100%

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each RSV asset appears in exactly one row. The 38 trials still recruiting or running carry 24% of the 156 registered trials in scope.

Which approved RSV medicines are still in trials?

1 medicines already on the market are still being tested in RSV Phase IV trials; Clesrovimab has the most, with 3 registered trials.

MedicineLead sponsorRegistered trials
ClesrovimabMerck Sharp & Dohme LLC3

Post-approval RSV 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 RSV trials are recruiting patients now?

21 RSV trials are recruiting patients and 3 more have not started recruiting yet, out of 156 interventional trials in scope; together they make up 15% of the trial base.

Registry statusTrialsShare
Completed9662%
Recruiting2113%
Terminated159.6%
Active, not recruiting149.0%
Status not verified42.6%
Withdrawn31.9%
Not yet recruiting31.9%

Terminated, suspended and withdrawn RSV 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 RSV pipeline?

Sanofi Pasteur, a Sanofi Company leads the RSV pipeline with 12 candidates; the top 5 sponsors hold 63% of the 48 assets, and 22 sponsors run at least one.

SponsorAssets in developmentShare
Sanofi Pasteur, a Sanofi Company1225%
Guangzhou Patronus Biotech Co., Ltd.613%
Sanofi510%
GlaxoSmithKline48.3%
Clover Biopharmaceuticals AUS Pty36.3%

Industry sponsors lead 127 of the 156 RSV trials (81%); 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 RSV pipeline?

Mechanism and drug-type classification for the 48 RSV 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 RSV trial readouts are coming next?

5 RSV 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
ZelicapavirEnanta Pharmaceuticals, IncPhase IIDec 2026 (estimated)NCT07482657
S-337395ShionogiPhase IIDec 2026 (estimated)NCT07214571
RSVPreF3 OAGlaxoSmithKlinePhase IIJan 2027 (estimated)NCT07092865

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 RSV readouts fall in each quarter?

7 RSV candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 2, due in Q4 2026.

QuarterPhase III readoutsPhase II readoutsTotal
Q4 2026022
Q1 2027011
Q2 2027101
Q3 2027011
Q4 2027011
Q1 2028101
Q2 2028000
Q3 2028000

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 RSV trials?

United States hosts the most RSV trials, with sites in 79 of the 156 studies (51%); trials in scope run in 57 countries in all.

CountryTrials with a siteShare of trials
United States7951%
United Kingdom3221%
Spain2919%
Australia2818%
China2717%
South Africa2516%
Japan2516%
Canada2415%

A multinational RSV 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 RSV drugs being tested?

79 of the 156 RSV trials (51%) have a site in the United States, 62 (40%) in Europe and 27 (17%) in China; 20 of the 48 candidates in development are tested in the US.

RegionTrials with a siteShare of trialsCandidates testedRegulator
United States7951%20FDA
Europe (EU/EEA, UK, Switzerland)6240%13EMA, MHRA, Swissmedic
China2717%10NMPA
Japan2516%4PMDA
Rest of world6240%36national 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 RSV 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 RSV pipeline since the last update?

This is the first edition of the RSV pipeline count, dated 3 Oct 2026. The next refresh is due by 1 Jan 2027, and each refresh lists the assets that entered, advanced or dropped out.

How does Douglas Insights count the RSV pipeline?

Douglas Insights read 156 interventional trials registered on ClinicalTrials.gov for the conditions "respiratory syncytial virus infections" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 48 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 RSV Pipeline Review include?

The RSV Pipeline Review covers all 48 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 48 candidates
01Executive summary and our call2–3 pp

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

OptionWhat you getDeliveryPrice
Pipeline SnapshotThis therapy area as published: PDF report + Excel trackerReady nowUSD 3,000Enquire
Pipeline ReviewYour indication, geography and phase cut-off; ranked calls and an analyst call2–3 weeksFrom USD 4,000Enquire
Company AssessmentOne sponsor's full pipeline against its peers2 weeksFrom USD 5,000Enquire

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Frequently asked questions about the RSV pipeline

How many drugs are in the RSV pipeline?

48 drug candidates are in active clinical development for RSV, with 7 in Phase III, per Douglas Insights (data as of 3 Oct 2026).

Which company has the most RSV drugs in development?

12 candidates make Sanofi Pasteur, a Sanofi Company the largest RSV pipeline sponsor, out of 22 sponsors counted by Douglas Insights.

When is the next RSV trial readout?

Dec 2026 is the registered primary completion of the Phase II trial of Zelicapavir (NCT07482657), the next RSV catalyst in Douglas Insights' calendar.

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

79 RSV trials have a US site and 62 a European site, out of 156 registered trials counted by Douglas Insights (data as of 3 Oct 2026).

How often is the RSV 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). RSV Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/rsv/