Nintedanib esylate in Idiopathic Pulmonary Fibrosis: NCT07344558 Clinical Landscape Report 2026
Explore the PatSnap Life Sciences MCP marketplace
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: 16 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
27
Planned enrollment
2026-06-17
Primary-completion proxy
Executive view
NCT07344558 evaluates Nintedanib esylate in Idiopathic Pulmonary Fibrosis. The disclosed sponsor is MannKind Corp., the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is (Cohort 1) Events of Bronchospasm, assessed over Up to Day 7.
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 NCT07344558 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 MannKind Corp..
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 |
|---|---|---|---|---|---|---|
| NCT07344558 | Nintedanib esylate | Phase 1 / Completed | MannKind Corp. | United States | (Cohort 1) Events of Bronchospasm Up to Day 7 | 2026-06-17 |
| NCT07600021 | SYH2059 | Phase 2 / Not yet recruiting | Sponsor not reported | Geography not reported | Change in FVC from baseline (mL) Week 12 | 2027-10-30 |
| NCT07593690 | HW241045 | Phase 1 / Not yet recruiting | Hubei Bio-Pharmaceutical Industrial Technological Institute | China | The number and severity of treatment emergent adverse events (TEAEs) From the first dose administration to 48 hours after the last dose. | 2027-01-01 |
| NCT07570888 | Nerandomilast | Phase 4 / Not yet recruiting | University of British Columbia | Geography not reported | Determine the persistency of nerandomilast at 4 months when used in combination with mycophenolate in patients with pul… Four months | 2027-06-01 |
| NCT07528703 | RC-010 | Phase 1 / Not yet recruiting | Nanjing Reju Therapeutics Co., Ltd. | China | The incidence of Treatment-emergent adverse events (TEAEs) Day1-Day14 | 2027-04-01 |
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.
Reproduce the trial-to-asset workflow with PatSnap MCP
Protocol design and endpoint interpretation
NCT07344558 is a Phase 1, completed study with 27 planned participants. Allocation is Randomized, masking is Double, and the intervention model is Sequential Assignment.
The primary endpoint is “(Cohort 1) Events of Bronchospasm” over “Up to Day 7.” The retrieved endpoint description is: The within-treatment number and proportion of participants with events of bronchospasm (e.g., treatment emergent adverse events \[TEAE\] immediately after inhalation of wheezing or chest tightness).
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 27 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 NCT07344558 unless the registration number matches.
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
Deupirfenidone compared with pirfenidone and placebo in idiopathic pulmonary fibrosis (ELEVATE-IPF): a phase 2b randomized placebo-controlled trial
Phase 2; n=257; FVC(change in) = -110.71 mL ( -148.75 to -70.98); FVC(change in) = -48.42 mL ( -87.66 to -9.04) Source: https://pubmed.ncbi.nlm.nih.gov/42085224/
Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis
Phase 3; n=593; FVC = -136.4 ml ( -172.5 to -104.0); FVC = -49.9 ml ( -79.2 to -19.5) Source: https://pubmed.ncbi.nlm.nih.gov/41812190/
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
No exact Drug & Asset MCP profile was returned for the protocol wording “Nintedanib esylate.” The report therefore avoids inferring modality, target or global development stage from the name alone.
MannKind Corp. is indexed in United States with the website http://www.mannkindcorp.com. MannKind focuses on the discovery and development of therapeutic products for patients with diseases such as diabetes. The record lists 9 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: NCT07344558
Protocol source: https://clinicaltrials.gov/study/NCT07344558
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: 16 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 (Cohort 1) Events of Bronchospasm and 2026-06-17 the leading decision points.
Build and refresh clinical landscape reports with PatSnap MCP
