Yinfenidone Hydrochloride in Idiopathic Pulmonary Fibrosis: NCT04512170 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: 16 October 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
not reported
Planned enrollment
2021-08-23
Primary-completion proxy
Executive view
NCT04512170 evaluates Yinfenidone Hydrochloride in Idiopathic Pulmonary Fibrosis. The disclosed sponsor is Sunshine Lake Pharma Co., Ltd., the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Safety and Tolerability of HEC585 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose and Multiple Ascending Doses, assessed over up to 18 days.
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 NCT04512170 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 Yinfenidone Hydrochloride, while Company & Deal Intelligence MCP organization_fetch was queried for Sunshine Lake Pharma Co., Ltd..
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 |
|---|---|---|---|---|---|---|
| NCT04512170 | Yinfenidone Hydrochloride | Phase 1 / Completed | Sunshine Lake Pharma Co., Ltd. | China | Safety and Tolerability of HEC585 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral… up to 18 days | 2021-08-23 |
| NCT05427253 | C-106 | Phase 1 / Completed | Vicore Pharma AB | Sweden | Total Number of Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs) From date of signing informed consent until End of Study, assessed up… | 2023-06-22 |
| NCT05428150 | Pirfenidone | Phase 1 / Completed | Excalibur Pharmaceuticals Inc | United States | AUC 0-inf Up to Day 6 of Periods 1 and 2 | 2022-09-25 |
| NCT05424887 | GDC-3280 | Phase 2 / Not yet recruiting | Shanghai Ark Biopharmaceutical Co., Ltd. | China | After 24 weeks of continuous medication, the absolute decrease in percentage of the predicted FVC from baseline in the… Up to 24 weeks | 2024-07-01 |
| NCT05417776 | [68Ga]CBP8 | Phase 2 / Recruiting | The General Hospital Corp. | United States | Degree of uptake of [68Ga]CBP8 24 months | 2026-10-01 |
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.
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Protocol design and endpoint interpretation
NCT04512170 is a Phase 1, completed study with not reported planned participants. Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment.
The primary endpoint is “Safety and Tolerability of HEC585 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose and Multiple Ascending Doses” over “up to 18 days.” The retrieved endpoint description is: To investigate the safety and tolerability of HEC585 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD and MAD.
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 not reported 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
0 recent result records were selected as contextual evidence for Idiopathic Pulmonary Fibrosis. These records do not establish direct evidence for NCT04512170 unless the registration number matches.
Indexed evidence status
No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.
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
Yinfenidone Hydrochloride is indexed as Small molecule drug with TGF-α x TGF-β biology and a global stage of Phase 3. The asset profile lists Dongguan Dongyangguang Pharmaceutical R&D Co. Ltd. as an originator or developer.
Sunshine Lake Pharma Co., Ltd. is indexed in an unreported country with the website https://www.dyg.cn. Sunshine Lake Pharma is a pharmaceutical drug development firm that aims to address infections, tumors, and metabolic disorders. The record lists 77 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 Yinfenidone Hydrochloride 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: NCT04512170
Protocol source: https://clinicaltrials.gov/study/NCT04512170
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 October 2026.
Yinfenidone Hydrochloride in Idiopathic Pulmonary Fibrosis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Safety and Tolerability of HEC585 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose and Multiple Ascending Doses and 2021-08-23 the leading decision points.
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