Galunisertib NCT07321860 Clinical Landscape 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 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 2/3

Clinical phase

Not yet recruiting

Recruitment status

60

Planned enrollment

2027-06-30

Primary-completion proxy

Executive view

NCT07321860 evaluates Galunisertib in Amyotrophic Lateral Sclerosis. The disclosed sponsor is Sponsor not reported, the design is Interventional, and the geographic footprint is Geography not reported. The first listed primary endpoint is Pharmacodynamic Biomarkers - Change from Baseline in GREM2 and TGF-β Pathway Marker Levels, assessed over Time Frame: Baseline to 24 Weeks.

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 NCT07321860 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Amyotrophic Lateral Sclerosis landscape. Drug & Asset MCP drug_fetch was queried for Galunisertib, while Company & Deal Intelligence MCP organization_fetch was queried for Sponsor not reported.

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
NCT07321860	Galunisertib	Phase 2/3 / Not yet recruiting	Sponsor not reported	Geography not reported	Pharmacodynamic Biomarkers - Change from Baseline in GREM2 and TGF-β Pathway Marker Levels Time Frame: Baseline to 24 Weeks	2027-06-30
NCT07589764	Beta-Hydroxy-Beta-Methylbutyrate	Phase 1 / Not yet recruiting	Duke University	United States	ALS Functional Rating Scale, Revised (ALSFRS-R) Baseline, month 3, month 9	2027-10-01
NCT07571174	LY-4256984	Phase 1 / Recruiting	Eli Lilly & Co.	Canada, Netherlands, Belgium, Germany, Spain	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to… Baseline Up to Week 96	2029-06-01
ACTRN12626000231347	ACE-2223	Phase 1 / Recruiting	Acelot, Inc.	Australia		Timing not reported
ACTRN12626000233325	ACE-2223	Phase 1 / Not yet recruiting	Acelot, Inc.	Australia		Timing not reported

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

NCT07321860 is a Phase 2/3, not yet recruiting study with 60 planned participants. Allocation is Randomized, masking is Single, and the intervention model is Parallel Assignment.

The primary endpoint is “Pharmacodynamic Biomarkers - Change from Baseline in GREM2 and TGF-β Pathway Marker Levels” over “Time Frame: Baseline to 24 Weeks.” The retrieved endpoint description is: Pharmacodynamic Biomarkers - Change from Baseline in GREM2 and TGF-β Pathway Marker Levels (CSF or plasma; Time Frame: Baseline to 24 Weeks). Definition: GREM2 (Gremlin-2) concentration in cerebrospinal fluid or plasma will be measured at baseline and 24 weeks. GREM2 is a TGF-β-inducible protein used to stratify patients (GREM2-positive) and serves as a proxy for TGF-β pathway activity. In addition, downstream TGF-β signaling biomarkers will be assessed over the same period, including phosphorylated SMAD2/3 (pSMAD2/3) in peripheral blood cells and plasminogen activator inhibitor-1 (PAI-1, SERPINE1) in plasma.….

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 60 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

The protocol identifies Galunisertib, Nerandomilast as control therapy. 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 Amyotrophic Lateral Sclerosis. These records do not establish direct evidence for NCT07321860 unless the registration number matches.

A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral S…

Phase 1/2; n=8; AE = 3 participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05683860

Expansion and Infusion of T-Regulatory Cells in Amyotrophic Lateral Sclerosis

Phase 1; n=3; Number of Participants With Treatment-related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.0) & Medical Dictionary for Regulatory Activities (MedDRA). = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT03241784

Safety and Efficacy of PrimeC in Amyotrophic Lateral Sclerosis

Phase 2; n=68; Drug-related adverse events = 4.3 % ; Drug-related adverse events = 20.0 % Source: https://pubmed.ncbi.nlm.nih.gov/41837970/

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 “Galunisertib.” The report therefore avoids inferring modality, target or global development stage from the name alone.

No exact Company & Deal Intelligence profile was returned for Sponsor not reported. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.

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 Galunisertib 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: NCT07321860
Protocol source: https://clinicaltrials.gov/study/NCT07321860
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.

Galunisertib in Amyotrophic Lateral Sclerosis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Pharmacodynamic Biomarkers - Change from Baseline in GREM2 and TGF-β Pathway Marker Levels and 2027-06-30 the leading decision points.

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