GLYDO (lidocaine hydrochloride) · SAGENT PHARMS
Lidocaine is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.
Details
- Status
- Prescription
- First Approved
- 2014-04-28
- Routes
- TOPICAL
- Dosage Forms
- JELLY
GLYDO Approval History
What GLYDO Treats
2 indicationsGLYDO is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Urethritis
GLYDO Boxed Warning
Life-threatening and fatal events in infants and young children Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Viscous 2% should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limit...
WARNING: Life-threatening and fatal events in infants and young children Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Viscous 2% should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed. To decrease the risk of serious adverse events with use of Lidocaine Viscous 2%, instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the prescription bottle safely out of reach of children.
GLYDO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to GLYDO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07054801 LIMSAH | 23-40755 | Ph 2 | not yet recruiting | IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage |
| NCT03854344 results posted | 143321 | Ph 4 | completed | Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain |
| NCT07205757 | R 751 | Ph 4 | recruiting | Adding Lidocaine to Custodiol Mixture |
| NCT06462781 LIGHT 1 | 23-267 | Ph 1 | completed | Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1 |
| NCT05670236 results posted | 32283 | Ph 4 | completed | Effect of Knee Pain on Walking Biomechanics |
| NCT04524130 | 610/2563(IRB3) | Ph 4 | completed | Intraoperative Lidocaine and Combined With Ketamine on Opioid After Bariatric Surgery |
| NCT05201313 LISPRAY | 0042698/P/GEN/ARCS | Ph 3 | completed | Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations |
| NCT03967197 | 2020-8355 | Ph 2, Ph 3 | completed | Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring |
| NCT03254394 results posted | 201705166 | Ph 1, Ph 2 | completed | Lidocaine for Oxaliplatin-induced Neuropathy |
| NCT03310970 results posted | 201701725 | Ph 4 | completed | Pharmacokinetics of Lidocaine in Healthy Adults |
| NCT03885596 results posted | CA-PS-205 | Ph 2 | completed | Open-Label CA-008 (Vocacapsaicin) in Bunionectomy |
| NCT03667001 COALAS | CTU 17/026 | Ph 3 | completed | Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery |
| NCT04491474 | 2020/514/169/20 | Ph 4 | completed | Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Methods at Treatment of Acute Migraine Attack in the Emergency Department |
| NCT03484650 | 2344 | Ph 3 | withdrawn | Systemic Lidocaine Infusion for Pain Control in Ventral Hernia |
| NCT03787147 VR adult | 2018-9613 | Ph 2 | withdrawn | Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI) |
| NCT03825016 | AS1855 | Ph 2 | completed | Lidocaine Infusion in Hystroscopy |
| NCT03096444 results posted | 20170087 | Ph 2 | terminated | Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine |
| NCT02120261 USAMPS results posted | HSC-MS-14-0072 | Ph 4 | terminated | Using Saline for Myofascial Pain Syndromes (USAMPS) |
| NCT02689856 Hydro/Lido | 143-6151-201 | Ph 2 | completed | Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
GLYDO FDA Label Details
Indications & Usage
Lidocaine is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.
WARNING: Life-threatening and fatal events in infants and young children Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and admi...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.