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Clinical Evidence

One injection. Multiple joints. A growing body of evidence.

Cingal is supported by a robust and expanding clinical evidence base, including randomised controlled trials, health economic data, real-world clinical experience, and repeat-injection safety data. Originally developed and extensively studied in knee osteoarthritis, Cingal has a strong clinical foundation supported by multiple Phase III studies.

Phase III Trial DataPublications & References

Four categories of clinical evidence

Key clinical data supports the efficacy, safety, economic and real-world use

Clinical Trials & Studies

Phase III randomised, double-blind, multicentre trials in knee OA. Pivotal study: 368 patients, 26-week follow-up. Trials compared Cingal to HA alone, TH alone, and saline.1,2,3

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Economic Modelling & Cost-Utility

Published cost-utility analysis comparing single-injection Cingal vs. a two-injection sequential regimen. Cingal dominated the comparator on both cost and QALYs.4

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Repeat Injections & Safety Profile

Safety data across three Phase III trials plus the Cingal 13-02 repeat-injection study (242 patients). No treatment-related serious adverse events.5

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Clinical Papers & Publications

Curated peer-reviewed publications, ClinicalTrials.gov registry links, and full reference list for use in clinical decision-making.

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Key Findings at a Glance

A clinical foundation built on Phase III evidence

Cingal’s evidence base spans clinical efficacy, health economics, long-term safety, and real-world practice. Selected highlights from across the clinical programme:

72%

WOMAC Pain Improvement

Improvement in WOMAC pain score at 26 weeks in the pivotal Phase III trial (368 patients, KL grades I–III).1

92%

OMERACT-OARSI Responders

Responder rate at 26 weeks using validated OMERACT-OARSI criteria, the standard for OA clinical trial response assessment.1

Less costly

vs. Two-Injection Regimen

Single-injection Cingal was less costly and at least as effective (QALYs gained) vs. sequential corticosteroid + HA injections over 6 months.4

Safety

Treatment-Related SAEs

No treatment-related serious adverse events across three Phase III studies. Adverse event profile consistent with established HA and corticosteroid use.5

Ready to review the full evidence?

Explore the Phase III data, economic modelling, and peer-reviewed literature in detail.

Phase III Evidence

Clinical Trials & Studies

Detailed trial methodology, WOMAC and OMERACT-OARSI outcome data, and comparative results from three Phase III studies.

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Peer-Reviewed Literature

Clinical Papers & Publications

Access the full publication list, PubMed links, and ClinicalTrials.gov registry entries for Cingal’s clinical programme.

View Publications