Interstitial Lung Disease has 86 drug candidates in active clinical development, of which 15 are in Phase III, 52 in Phase II and 19 in Phase I, according to Douglas Insights' count of 525 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).
The interstitial lung disease 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 interstitial lung disease drugs are in each phase of development?
Douglas Insights counts 15 interstitial lung disease candidates in Phase III, 17% of the 86 assets in development; Phase II holds 52 and Phase I holds 19.
| Phase (highest reached) | Assets | Share of pipeline |
|---|---|---|
| Phase III | 15 | 17% |
| Phase II | 52 | 60% |
| Phase I | 19 | 22% |
| Total | 86 | 100% |
Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each interstitial lung disease asset appears in exactly one row. The 238 trials still recruiting or running carry 45% of the 525 registered trials in scope.
Which approved interstitial lung disease medicines are still in trials?
2 medicines already on the market are still being tested in interstitial lung disease Phase IV trials; Pirfenidone has the most, with 28 registered trials.
| Medicine | Lead sponsor | Registered trials |
|---|---|---|
| Pirfenidone | Several sponsors | 28 |
| Nintedanib | Several sponsors | 25 |
Post-approval interstitial lung disease 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 interstitial lung disease trials are recruiting patients now?
132 interstitial lung disease trials are recruiting patients and 46 more have not started recruiting yet, out of 525 interventional trials in scope; together they make up 34% of the trial base.
| Registry status | Trials | Share |
|---|---|---|
| Completed | 192 | 37% |
| Recruiting | 132 | 25% |
| Active, not recruiting | 56 | 11% |
| Not yet recruiting | 46 | 8.8% |
| Status not verified | 42 | 8.0% |
| Terminated | 39 | 7.4% |
| Withdrawn | 10 | 1.9% |
| Suspended | 4 | 0.8% |
| Enrolling by invitation | 4 | 0.8% |
Terminated, suspended and withdrawn interstitial lung disease trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted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 interstitial lung disease pipeline?
GlaxoSmithKline leads the interstitial lung disease pipeline with 3 candidates; the top 5 sponsors hold 15% of the 86 assets, and 72 sponsors run at least one.
| Sponsor | Assets in development | Share |
|---|---|---|
| GlaxoSmithKline | 3 | 3.5% |
| Boehringer Ingelheim | 3 | 3.5% |
| Novartis Pharmaceuticals | 3 | 3.5% |
| AstraZeneca | 2 | 2.3% |
| Chiesi Farmaceutici S.p.A. | 2 | 2.3% |
Industry sponsors lead 249 of the 525 interstitial lung disease trials (47%); 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 interstitial lung disease pipeline?
Mechanism and drug-type classification for the 86 interstitial lung disease 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 interstitial lung disease trial readouts are coming next?
22 interstitial lung disease 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 |
|---|---|---|---|---|
| DWN12088 | Daewoong Pharmaceutical Co. LTD. | Phase II | Oct 2026 (estimated) | NCT05389215 |
| Taladegib | Endeavor Biomedicines, Inc. | Phase II | Oct 2026 (estimated) | NCT06422884 |
| HSK44459 | Haisco Pharmaceutical Group Co., Ltd. | Phase II | Oct 2026 (estimated) | NCT07019090 |
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 interstitial lung disease readouts fall in each quarter?
41 interstitial lung disease candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 13, due in Q4 2026.
| Quarter | Phase III readouts | Phase II readouts | Total |
|---|---|---|---|
| Q4 2026 | 0 | 13 | 13 |
| Q1 2027 | 1 | 2 | 3 |
| Q2 2027 | 0 | 3 | 3 |
| Q3 2027 | 0 | 3 | 3 |
| Q4 2027 | 2 | 4 | 6 |
| Q1 2028 | 0 | 5 | 5 |
| Q2 2028 | 1 | 4 | 5 |
| Q3 2028 | 1 | 2 | 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 interstitial lung disease trials?
United States hosts the most interstitial lung disease trials, with sites in 248 of the 525 studies (47%); trials in scope run in 65 countries in all.
| Country | Trials with a site | Share of trials |
|---|---|---|
| United States | 248 | 47% |
| China | 127 | 24% |
| United Kingdom | 98 | 19% |
| Australia | 86 | 16% |
| France | 85 | 16% |
| Germany | 80 | 15% |
| Canada | 79 | 15% |
| Spain | 73 | 14% |
A multinational interstitial lung disease 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 interstitial lung disease drugs being tested?
248 of the 525 interstitial lung disease trials (47%) have a site in the United States, 169 (32%) in Europe and 127 (24%) in China; 48 of the 86 candidates in development are tested in the US.
| Region | Trials with a site | Share of trials | Candidates tested | Regulator |
|---|---|---|---|---|
| United States | 248 | 47% | 48 | FDA |
| Europe (EU/EEA, UK, Switzerland) | 169 | 32% | 40 | EMA, MHRA, Swissmedic |
| China | 127 | 24% | 27 | NMPA |
| Japan | 41 | 7.8% | 12 | PMDA |
| Rest of world | 176 | 34% | 45 | 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 interstitial lung disease 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 interstitial lung disease pipeline since the last update?
Since 3 Oct 2026, the interstitial lung disease pipeline count moved by +1 assets to 86, Phase III moved by 0 and the trial base by 0.
How does Douglas Insights count the interstitial lung disease pipeline?
Douglas Insights read 525 interventional trials registered on ClinicalTrials.gov for the conditions "Lung Diseases, Interstitial", "interstitial lung disease" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 86 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 Interstitial Lung Disease Pipeline Review include?
The Interstitial Lung Disease Pipeline Review covers all 86 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 interstitial lung disease 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 interstitial lung disease 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 interstitial lung disease, 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 Interstitial Lung Disease 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 interstitial lung disease pipeline
How many drugs are in the interstitial lung disease pipeline?
86 drug candidates are in active clinical development for interstitial lung disease, with 15 in Phase III, per Douglas Insights (data as of 3 Oct 2026).
Which company has the most interstitial lung disease drugs in development?
3 candidates make GlaxoSmithKline the largest interstitial lung disease pipeline sponsor, out of 72 sponsors counted by Douglas Insights.
When is the next interstitial lung disease trial readout?
Oct 2026 is the registered primary completion of the Phase II trial of DWN12088 (NCT05389215), the next interstitial lung disease catalyst in Douglas Insights' calendar.
How many interstitial lung disease trials run in the United States and Europe?
248 interstitial lung disease trials have a US site and 169 a European site, out of 525 registered trials counted by Douglas Insights (data as of 3 Oct 2026).
How often is the interstitial lung disease 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). Interstitial Lung Disease Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/interstitial-lung-disease/