TJ-68 in Muscle Cramp: NCT04998305 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 1/2
Clinical phase
Completed
Recruitment status
not reported
Planned enrollment
2024-07-26
Primary-completion proxy
Executive view
NCT04998305 evaluates TJ-68 in Muscle Cramp. The disclosed sponsor is Columbia University, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Visual Analog Scale (MCS-VAS) Score, assessed over Assessed at Baseline, Week 2, Week 5, Week 8 and Week 11; Week 2 reported.
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 NCT04998305 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Muscle Cramp landscape. Drug & Asset MCP drug_fetch was queried for TJ-68, while Company & Deal Intelligence MCP organization_fetch was queried for Columbia University.
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 |
|---|---|---|---|---|---|---|
| NCT04998305 | TJ-68 | Phase 1/2 / Completed | Columbia University | United States | Visual Analog Scale (MCS-VAS) Score Assessed at Baseline, Week 2, Week 5, Week 8 and Week 11; Week 2 repo… | 2024-07-26 |
| NCT05797701 | Oditrasertib | Phase 1 / Completed | Sanofi | United States | Part 1: Maximum plasma concentration observed (Cmax) In both Period 1 and Period 2: From Day 1 to Day 3 | 2021-09-06 |
| NCT05797753 | Itraconazole | Phase 1 / Completed | Sanofi | United States | Part A: SAR443820: Area under the plasma concentration from time zero to the last concentration above the limit of quan… Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10 | 2022-07-01 |
| NCT05795907 | Oditrasertib | Phase 1 / Completed | Sanofi | United States | Parts 1a and 1b: Number of participants with adverse events Day1 up to Day 7 (end of study visit) | 2021-07-20 |
| NCT05753852 | Tauroursodeoxycholate sodium | Phase 3 / Unknown status | Humanitas Mirasole SpA | Netherlands, Belgium, Ireland, United Kingdom, Italy, France, Germany | Long-term safety and tolerability of TUDCA during the open-label phase 18 months | 2025-03-31 |
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
NCT04998305 is a Phase 1/2, completed study with not reported planned participants. Allocation is Randomized, masking is Triple, and the intervention model is Crossover Assignment.
The primary endpoint is “Visual Analog Scale (MCS-VAS) Score” over “Assessed at Baseline, Week 2, Week 5, Week 8 and Week 11; Week 2 reported.” The retrieved endpoint description is: This is designed to measure improvements in muscle cramps. MCS-VAS indicates the level to which muscle cramps affect overall daily activity. The score ranges from 0 to 10; 0 indicates no interference and 10 indicates severe interference with overall daily activity. MCS-VAS will be administered by a trained evaluator to reduce recall bias and lack of insight, which can limit subjective assessments. To minimize carryover effects, results reflect the average of the scores taken at the second week of each treatment period..
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 Muscle Cramp. These records do not establish direct evidence for NCT04998305 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
TJ-68 is indexed as Herbal medicine with target not reported biology and a global stage of Pending. The asset profile lists The Trustees of Columbia University in The City of New York as an originator or developer.
Columbia University is indexed in an unreported country with the website https://www.arch.columbia.edu. Columbia GSAPP is an educational institution that provides School, Programs, Research, Resources, and Admissions. The record lists 31 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 TJ-68 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: NCT04998305
Protocol source: https://clinicaltrials.gov/study/NCT04998305
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.
TJ-68 in Muscle Cramp is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Visual Analog Scale (MCS-VAS) Score and 2024-07-26 the leading decision points.
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