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Proven safety in clinical trials

Across three Phase III clinical studies,1,2,3 Cingal demonstrated a strong and consistent safety profile, with no treatment-related serious adverse events and a tolerability profile in line with established hyaluronic acid and corticosteroid treatments.

Repeat Injection Data

Safety Profile at a Glance

  • No treatment-related serious adverse events across 3 Phase III studies
  • Low incidence of mild, transient local reactions
  • Safety profile consistent with established HA and corticosteroid injections
  • No new safety concerns in repeat-injection follow-up study (n=242)

Consistent safety across all three Phase III studies

Safety data from three independent Phase III studies (comparing Cingal against HA alone,1 TH alone,2 and saline3) provide a comprehensive and consistent safety picture.

Zero Treatment-Related Serious Adverse Events

No treatment-related SAEs reported across all three Phase III clinical studies.

Low Incidence of Local Reactions

Any local reactions observed were mild and transient, consistent with the known profile for intra-articular injections.

Profile Aligned with Established Components

Overall safety profile consistent with established HA and corticosteroid intra-articular injections across all three comparator arms.

Repeat injection safety: Cingal 13-02 follow-up study

The Cingal 13-024 open-label follow-up study was specifically designed to evaluate the safety of repeat injections in patients previously treated with Cingal, directly addressing one of the key clinical questions for long-term OA management.

  • Design Open label safety study
  • Patients enrolled 242
  • Population Previously treated with Cingal
  • Primary focus Adverse events & joint examination findings following repeat injection
  • Reference Data on File 13-024

The study evaluated adverse events and joint examination findings following a repeat Cingal injection in patients with prior Cingal exposure. Results confirmed the safety profile seen in the Phase III programme:

  • No new safety concerns identified

    The repeat injection study found no new safety concerns in patients receiving a second Cingal injection, confirming that the safety profile is maintained with repeat administration, an important consideration for patients requiring annual OA management.

  • Adverse events consistent with known HA and corticosteroid profiles

    Any adverse events observed were consistent with the known safety profiles of hyaluronic acid and corticosteroid intra-articular injections, providing reassurance for prescribers managing patients across multiple injection cycles.

Both components carry a long-established safety record

25+

Years of Clinical Use

Hyaluronic Acid Injections

Hyaluronic acid intra-articular injections have been used in clinical practice for over 25 years, establishing a well-understood tolerability and safety profile across a large patient population.

40+

Years of Clinical Use

Corticosteroid Injections

Corticosteroid intra-articular injections have been used for inflammation management in orthopaedic and rheumatological practice for over 40 years, one of the most extensively characterised procedures in musculoskeletal medicine.