TheraRadar
Data updated: May 26, 2026

PLIAGLIS (lidocaine)

Pain Approved 2006-06-29

PLIAGLIS is indicated for the treatment of Pain; Soreness; Burning; Itching; Hemorrhoids; Anorectal Discomfort.

Source: FDA Label • CRESCITA THERAP
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
19
Years on Market

Details

Status
Prescription
First Approved
2006-06-29
Patent Cliff
2031

Pro Metrics

Patent cliff and revenue data

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Routes
TOPICAL
Dosage Forms
CREAM

Companies

CRESCITA THERAP
Active Ingredient: LIDOCAINE , TETRACAINE

PLIAGLIS Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2006 to 2018
Dec 2018 SUPPL
Label · Labeling
FDA Letter Label
Nov 2018 SUPPL
Label · Labeling
FDA Letter Label
Nov 2017 SUPPL
Label · Labeling
FDA Letter Label

What PLIAGLIS Treats

6 indications

PLIAGLIS is approved for 6 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pain
  • Soreness
  • Burning
  • Itching
  • Hemorrhoids
  • Anorectal Discomfort
Source: FDA Label

PLIAGLIS Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

BYQLOVI
HARROW EYE
2024 2 indic.
DIFLUPREDNATE
Viatris
2021 3 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

223 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 223 trials

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Active Pipeline

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Key Completed Trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

PLIAGLIS FDA Label Details

Indications & Usage

FDA Label (PDF)

PLIAGLIS is indicated for the treatment of Pain; Soreness; Burning; Itching; Hemorrhoids; Anorectal Discomfort.

View full patent landscape →
3 OB patents · 1 families · 26 international docs across 8 countries

PLIAGLIS Patents & Exclusivity

Latest Patent: Jan 2031

Patents (4 active)

US12558328 Expires Jan 14, 2031
US10603293 Expires Jan 14, 2031
US10751305 Expires Jan 14, 2031
US10350180 Expires Jan 14, 2031
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2031
  • • 4 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA021717 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.