Data updated: May 26, 2026
ORAQIX (lidocaine)
Pain
Approved 2003-12-19
ORAQIX is indicated for the treatment of Pain; Soreness; Burning; Itching; Hemorrhoids; Anorectal Discomfort.
Source: FDA Label • DENTSPLY PHARM
1
Indication
--
Phase 3 Trials
22
Years on Market
Details
- Status
- Prescription
- First Approved
- 2003-12-19
- Routes
- PERIODONTAL
- Dosage Forms
- GEL
ORAQIX Approval History
2004
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2022
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2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2003 to 2022
Mar 2022 SUPPL
Label · Labeling
What ORAQIX Treats
6 indicationsORAQIX is approved for 6 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Soreness
- Burning
- Itching
- Hemorrhoids
- Anorectal Discomfort
Source: FDA Label
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Clinical Trial Registry
222 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05378113 results posted | STUDY00001599 | Ph 2 | terminated | Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial |
| NCT07354217 PFA_workflow | 202512001MIPA | Ph 4 | not yet recruiting | Workflow Optimization During Pulse Field Ablation for Atrial Fibrillation |
| NCT04716699 | UCDCC#285 NCI-2020-14099, UCDCC#285 | Ph 1 | completed | Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma |
| NCT05044468 | 2019-0237 NCI-2021-08954, 2019-0237 | Ph 2 | active not recruiting | EXPAREL or Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement |
| NCT07432399 PILDI | ORI2025-16 2025-521808-22-00 | Ph 2 | recruiting | Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study) |
| NCT07401745 TMD | R.25.10.27 | Ph 4 | active not recruiting | Occlusal Splint Combined With Granisetron Injection for Management of Myofascial Pain Related to Temporomandibular Disorders |
| NCT06772727 | MD-265-2024 | Ph 4 | completed | Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy |
| NCT05844930 results posted | HSC-MS-21-0706 | Ph 4 | completed | A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder |
| NCT07445191 | injection of masseter muscle | Ph 2, Ph 3 | not yet recruiting | Efficacy of Triamcinolone-Lidocaine Mix in Trigger Points Injection of Masseter Muscle: Double-blinded, Randomized Controlled Trial |
| NCT07425678 | ERC NUMBER- 2025-9126-34025 | Ph 4 | completed | Comparison of Systemic Opioid (Morphine) and Pre-Incision Bilateral Scalp Nerve Block for Pain Management in Craniotomy Patients |
| NCT03211455 XYLOBAR | 17-014 | Ph 3 | completed | Intravenous Lidocaine in Bariatric Surgery. |
| NCT06661902 BURN | RG1125023 STUDY00021446, NCI-2024-10011 | Ph 1, Ph 2 | completed | Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial |
| NCT06923787 PILDI | ORI2025-016 2025-521808-22-01 | Ph 2 | recruiting | Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patients Undergoing Surgery for Colon Cancer - the PILDI Study |
| NCT02591199 results posted | URG101-105 | Ph 2 | terminated | Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome |
| NCT04781673 | 2019-508 | Ph 4 | active not recruiting | Ketamine vs Lidocaine in Traumatic Rib Fractures |
| NCT05737121 | VNX001-111; Engage 2024 | Ph 2 | recruiting | Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS |
| NCT05153785 | Lidokain vid leverkirurgi 2019-002361-35 | Ph 2, Ph 3 | completed | Perioperative Intravenous Lidocaine in Liver Surgery |
| NCT07294118 | 25-0010 | Ph 2 | recruiting | Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage |
| NCT06910241 | 2195722 | Ph 3 | recruiting | Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs |
| NCT06045936 | 22-010792 | Ph 4 | recruiting | A Study of Contralateral Limb Block |
| NCT02525016 SPIRAL | 69HCL15_0057 | Ph 3 | completed | Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery |
| NCT07259772 | LW-20241021002-01 | Ph 4 | active not recruiting | Anesthetic Effect of Ropivacaine on Local Infiltration Anesthesia in Arteriovenous Fistula Surgery |
| NCT03453723 PROPLIDHYPNO | RC31/17/0041 2017-002630-22 | Ph 4 | completed | Pain Prevention During Propofol Infusion in Pediatric: Hypnoanalgesia of the Hand Versus Lidocaine. |
| NCT06653400 | STUDY-23-01631 | Ph 1 | recruiting | Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy |
| NCT07213037 | Magnesium Sulfate vs Lidocaine | Ph 3 | not yet recruiting | Magnesium Sulfate Versus Lidocaine as Additives to Dexmedetomidine for Cough Suppression After Functional Endoscopic Sinus Surgery |
| NCT01106716 | KAI-1678-003 | Ph 2 | completed | Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia |
| NCT02226159 SPIES results posted | 9086-14019 | Ph 4 | completed | Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain |
| NCT05017246 results posted | 202105007 | Ph 2 | terminated | Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy |
| NCT05732532 | 22-007855 | Ph 4 | completed | Steroids in Occipital Nerve Block for Treatment of Headache |
| NCT05809453 results posted | STU-2023-0094 | Ph 1, Ph 2 | completed | Intranasal Cocaine and Temperature Regulation During Exercise |
| NCT07048769 | 2024-16284 | Ph 4 | recruiting | Paracervical Block for Pain Reduction in Saline Infusion Sonograms |
| NCT06979141 MgSO4/DEX | MD/AZ.AST./AIP029/7/240/2/2025 | Ph 3 | recruiting | Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression After General Anesthesia |
| NCT04084548 | FLA 18-088 | Ph 3 | active not recruiting | Perioperative Lidocaine and Ketamine in Abdominal Surgery |
| NCT06795100 ElderLIDO_1 | 35RC23_9774_07_ElderLIDO_1 | Ph 4 | recruiting | Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients |
| NCT03865940 results posted | TN | Ph 2 | completed | Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy |
| NCT06391125 LIMIT | 202401099 | Ph 3 | recruiting | LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment |
| NCT05443009 | 030422 | Ph 4 | completed | Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction |
| NCT02595463 | 2015-741 | Ph 2, Ph 3 | completed | Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients |
| NCT04176419 | CASE6319 | Ph 3 | terminated | Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery |
| NCT04500158 results posted | HM20018316 | Ph 3 | completed | The Effect of Local Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort |
| NCT04356352 results posted | IRB00063576 | Ph 2, Ph 3 | terminated | Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain |
| NCT06539143 | NHREC/16/05/22/209 | Ph 4 | completed | Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration |
| NCT02229578 LidocaineBurn results posted | IRB201400019 OCR18920 | Ph 4 | completed | Lidocaine For Treatment of Post-operative Pain From Donor Sites Following Burn Injury. |
| NCT04648891 results posted | 20-006889 | Ph 2, Ph 3 | completed | Spasmodic Dysphonia Pain |
| NCT03597776 | UW18-276 | Ph 4 | completed | Intravenous Lidocaine in Total Knee Replacement |
| NCT04069169 P-IVLT | H18-03103 | Ph 3 | completed | IV Lidocaine Analgesia in Pediatric Scoliosis Surgery |
| NCT05750056 | K2020-05-029-02 | Ph 4 | completed | Dose Systemic Lidocaine Improve the Quality of Recovery After Colorectal Endoscopic Submucosal Dissection |
| NCT04591353 (PENG) results posted | IRB-300006163 | Ph 3 | completed | Trial Comparing Impact of PENG Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty |
| NCT04250805 GASTROXY | 2019-1201 2019-004835-22 | Ph 2 | terminated | Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy |
| NCT04216017 results posted | STUDY00007576 P30AR072572 | Ph 2 | completed | Glenohumeral Cortisone Injection |
Showing 50 of 222 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ORAQIX FDA Label Details
Indications & Usage
FDA Label (PDF)ORAQIX is indicated for the treatment of Pain; Soreness; Burning; Itching; Hemorrhoids; Anorectal Discomfort.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.