Nintedanib esylate in Idiopathic Pulmonary Fibrosis: ACTRN12624000825550 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Completed
Recruitment status
68
Planned enrollment
2024-12-22
Primary-completion proxy
Executive view
ACTRN12624000825550 evaluates Nintedanib esylate in Idiopathic Pulmonary Fibrosis. The disclosed sponsor is Avalyn Pharma, Inc., the design is Interventional, and the geographic footprint is Australia. The first listed primary endpoint is not reported, assessed over an unreported time frame.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for ACTRN12624000825550 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Idiopathic Pulmonary Fibrosis landscape. Drug & Asset MCP drug_fetch was queried for Nintedanib esylate, while Company & Deal Intelligence MCP organization_fetch was queried for Avalyn Pharma, Inc..
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| ACTRN12624000825550 | Nintedanib esylate | Phase 1 / Completed | Avalyn Pharma, Inc. | Australia | 2024-12-22 | |
| NCT06747923 | SB17170 | Phase 2 / Recruiting | Sparkbiopharma Co., Ltd. | South Korea | Change from baseline in FVC (ml) Week 12 | 2026-05-30 |
| NCT06736990 | CAL-101 (Calluna) | Phase 2 / Active, not recruiting | Calluna Pharma, Inc. | South Korea, Netherlands, Romania, Norway, United States, Turkey, Denmark, United Kingdom, Italy, France, Spain | Change from baseline in forced vital capacity (FVC) compared to placebo 28 weeks | 2026-11-01 |
| NCT06714123 | Senicapoc | Phase 2 / Recruiting | Vejle Hospital | Denmark, United Kingdom, Estonia | The rate of decline of forced vital capacity (FVC) in mL of predicted. 26 weeks | 2028-12-01 |
| NCT06683612 | PIPE-791 | Phase 1 / Completed | Contineum Therapeutics, Inc. | United Kingdom | LPA1 occupancy as determined by regional total volume of distribution (VT) at each brain scan. Baseline to up to 28 days post-dose | 2025-06-04 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
ACTRN12624000825550 is a Phase 1, completed study with 68 planned participants. Allocation is Randomised controlled trial, masking is Blinded (masking used), and the intervention model is not reported.
The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: To assess the safety and tolerability profile of AP02 when administered in healthy volunteers as single ascending doses (SAD, Part 1).[The incidence, frequency, and severity of adverse events (AEs)/serious adverse events (SAEs) including clinically significant vital signs (systolic/diastolic blood pressure via sphygmomanometer, heart rate via pulse oximeter, respiratory rate via manual count, oximetry via pulse oximeter, and temperature via tympanic thermometer), electrocardiograms (ECGs), spirometry, oximetry, laboratory test results, and physical examinations. Examples of potential adverse events include: gast….
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 68 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Idiopathic Pulmonary Fibrosis. These records do not establish direct evidence for ACTRN12624000825550 unless the registration number matches.
A Phase IIa/IIb, Randomised, Double Blind, Placebo-controlled, Parallel-group Dose-finding Study to Examine the Efficacy and Safety of BI 1839100 Administered Orally Over a 12-wee…
Phase 2; n=85; Phase IIa: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 4(Least Squares Mean): Estimated treatment difference (%) = -18.30(95% CI, -45.42 to 22.30); Estimated treatment difference (%) = 6.69(95% CI, -28.41 to 58.99); Estimated treatment difference (%) = -5.67(95% CI, -31.88 to 30.63); Phase IIa: Change From Baseline in 24-h Cough Frequency (CC/h) at Week 4(Least Squares Mean) = -20.97 Percentage of ch… Source: https://clinicaltrials.gov/ct2/show/results/NCT06360094
A Phase 2, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study (TRANSFORM) to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmona…
Phase 2; n=158; Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 26(Median) = -79.0 Milliliters (mL) (95% Confidence Interval, -125.5 to -10.2); Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 26(Median): Posterior median difference = -33.0(95% CI, -112.7 to 39.5) Source: https://clinicaltrials.gov/ct2/show/results/NCT06317285
A Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy and Safety of Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosi…
Phase 2; n=320; Change From Baseline in Forced Vital Capacity at Week 52(Mean) = 38.0 mL (Standard Deviation, NA); Change From Baseline in Forced Vital Capacity at Week 52(Mean) = 176.0 mL (Standard Deviation, NA) Source: https://clinicaltrials.gov/ct2/show/results/NCT06097260
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Nintedanib esylate is indexed as Small molecule drug with CSF-1R x FGFRs x FLT3 biology and a global stage of Approved. The asset profile lists Boehringer Ingelheim International GmbH as an originator or developer.
Avalyn Pharma, Inc. is indexed in United States with the website http://www.avalynpharma.com. Operates as a clinical-stage biopharmaceutical company that develops inhaled therapies to treat rare respiratory & interstitial lung diseases The record lists 3 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Nintedanib esylate is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: ACTRN12624000825550
Protocol source: https://anzctr.org.au/ACTRN12624000825550.aspx
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.
Nintedanib esylate in Idiopathic Pulmonary Fibrosis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes the primary endpoint and 2024-12-22 the leading decision points.
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