TheraRadar
Data updated: May 26, 2026

PLENVU (ascorbic acid)

Trial Activity: Expansion 2 active trials
Gastrointestinal Approved 2018-05-04

PLENVU is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult patients. It facilitates bowel evacuation to ensure the digestive tract is sufficiently cleared for medical imaging and examination.

Source: FDA Label • SALIX
Jump to: Indications Approvals Trials Competitors Safety Patents

How PLENVU Works

PLENVU exerts its effect through the osmotic action of its multi-component formulation. Dose 1 consists of PEG 3350 and sodium sulfate, while Dose 2 contains PEG 3350, sodium ascorbate, and ascorbic acid. These components work together to increase water retention within the lumen of the colon, resulting in loose stools and effective colonic cleansing.

Source: FDA Label

Development Insights

Norgine conducting 1 trials (33%)
3 indications explored (Focused)
→ bowel cleansing prior to clinical procedures (1 trials)
→ colon disease (1 trials)
→ colorectal cancer (1 trials)
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2018-05-04
Patent Cliff
2033

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
FOR SOLUTION

Companies

SALIX
Active Ingredient: ASCORBIC ACID , POLYETHYLENE GLYCOL 3350 , POTASSIUM CHLORIDE , SODIUM ASCORBATE , SODIUM CHLORIDE , SODIUM SULFATE

PLENVU Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2018 to 2023
Sep 2023 SUPPL
Label · Labeling
FDA Letter Label
May 2021 SUPPL
Label · Labeling
FDA Letter Label
May 2019 SUPPL
Label · Labeling
FDA Letter Label

What PLENVU Treats

1 indications

PLENVU is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Colon cleansing in preparation for colonoscopy
Source: FDA Label

PLENVU Competitive Set

Pro

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

Indication competitors

3

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

CLENPIQ
FERRING PHARMS
2017 1 indic.
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
NOVEL LABS
2011 2 indic.
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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

48 trials
Trial Sponsor ID Phase Status Title
NCT04138394 VICToRY VICToRY Ph 3 suspended VItamin C in Thermal injuRY: The VICToRY Trial
NCT04756063 PARTI 2020-1153 A530900, SMPH/ANESTHESIOLOGY Ph 4 suspended Parenteral Ascorbic Acid Repletion in TransplantatIon
NCT02905591 XACT-LUNG 201712770 3P30CA086862, 5U01CA140206 Ph 2 active not recruiting A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC
NCT05849129 AIVAA 20220721-01H Ph 2 recruiting Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer
NCT02344355 201504786 Ph 2 active not recruiting A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme
NCT01550510 results posted 11D.459 JT 1548 Ph 1, Ph 2 terminated Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA
NCT01555489 results posted 11D.365 JT 2181 Ph 2 terminated Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
NCT04046094 results posted IIT-2019-IVC_CarboGem UL1TR002366 Ph 1, Ph 2 active not recruiting Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients
NCT05436054 122021 Ph 4 recruiting A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy
NCT04516681 Vitamin C-GLUT3-2020 Ph 3 recruiting Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer
NCT02420314 results posted 201412760 3P30CA086862 Ph 2 completed Pharmacological Ascorbate for Lung Cancer
NCT06421688 YXLL-KY-2024(039) Ph 2 not yet recruiting Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery
NCT06224881 MS-362-2019 Ph 4 completed Vitamin C Deficiency in Septic Shock
NCT02969681 Vitality VitC001 Ph 3 completed Vitamin C Intravenously With Chemotherapy in Advanced Colorectal Cancer
NCT03410030 AA NABPLAGEM SU2C HRI NPG-002 Ph 1, Ph 2 completed Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM)
NCT04297423 LOWOL HCB/2019/0872 Ph 4 completed Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy
NCT02209636 results posted CLNB-006-13F CX001030 Ph 4 completed Phosphate Lowering in CKD Trial
NCT04354428 results posted STUDY00009878 INV-017062 Ph 2, Ph 3 terminated Treatment for COVID-19 in High-Risk Adult Outpatients
NCT03334409 results posted ACCRU-GU-1703 NCI-2017-01998, ACCRU-GU-1703 Ph 2 terminated Pazopanib Hydrochloride With or Without Ascorbic Acid in Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed by Surgery
NCT04328961 results posted STUDY00009750 INV-016204 Ph 2, Ph 3 completed Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)
NCT03422159 ORANGES results posted 17-004 Ph 2 completed Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.
NCT03397173 CASE1917 Ph 2 completed TET2 Mutations in Myelodysplastic Syndromes and Acute Myeloid Leukemia With Azacitidine + Ascorbic Acid
NCT03123107 2016-0463 Ph 1 completed Vitamin C in Cardiac Surgery Patients
NCT02734147 results posted 603204 Ph 2 terminated High Dose Intravenous Ascorbic Acid in Severe Sepsis
NCT04135378 KufaU2 Ph 4 completed Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation
NCT02106975 CITRIS-ALI results posted HM20000917 1UM1HL116885-01 Ph 2 completed Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury
NCT03226431 ARINA-1 Pro00080819 Ph 1 completed Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0
NCT02762331 results posted HM20000539 Ph 1 terminated High Dose Vitamin C in Cardiac Surgery Patients
NCT03697239 181045 Ph 1, Ph 2 withdrawn High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer
NCT03797443 PAN-VITC Ph 1, Ph 2 withdrawn High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer
NCT03908333 PRO00034648 Ph 1, Ph 2 withdrawn High Dose Ascorbic Acid and Nanoparticle Paclitaxel Protein Bound and Cisplatin and Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer
NCT02868151 ECR/227/INSP/AP/2014 Ph 2, Ph 3 completed Effect of Oral Vitamin C in Assessing the Severity of Oral Mucositis in Chemoradiation of Head and Neck Cancers
NCT03066115 2016-1014 Ph 1 withdrawn Impact of NOS, COX, and ROS Inhibition on Cerebral Blood Flow Regulation
NCT00953212 results posted MMC-3514 Ph 3 completed Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
NCT02793648 PI-0290-2012 Ph 2 completed Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.
NCT01434121 results posted HM12903 Ph 1, Ph 2 completed Ascorbic Acid (Vitamin C) Infusion in Human Sepsis
NCT01715597 SNUBH_GO_016 Ph 3 completed Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma
NCT02455180 NL50578.029.14 2014-003680-38 Ph 4 completed Pharmacokinetics of Two Different High-dose Regimens of Intravenous Vitamin C in Critically Ill Patients
NCT02521077 MZ2015010 Ph 2 withdrawn Intravenous Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer
NCT01587963 VitC results posted 0220100048 Ph 2 terminated High Dose Vitamin C in the Critically Ill Patient
NCT02602483 JAN12006-01 Ph 1, Ph 2 completed Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).
NCT02745873 LDVC LDVC Ph 2, Ph 3 completed Lead Detoxifying Effects of Ascorbic Acid Among School Going Adolescents of Karachi- A Cluster Randomized Control Trial
NCT02606773 NVP-14C Ph 1 completed "Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects
NCT01332578 results posted C7591227 Ph 4 completed A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies
NCT01580683 WU0811SB Ph 3 withdrawn Vitamin C and Atrial Fibrillation After Cardiac Surgery
NCT01322061 ANES.GK.06 AUBMC Ph 4 completed Vitamin C Efficacy in Reducing Post Operative Pain
NCT00519337 AFIST WHIT002743HE Ph 4 completed Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation
NCT01270152 0925-0586 Ph 2 completed Determining the Safe Dosage of Ascorbic Acid Used in the Treatment of Occluded Totally Implanted Central Venous Catheter
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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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.

PLENVU FDA Label Details

Indications & Usage

FDA Label (PDF)

PLENVU is indicated for the treatment of Colon cleansing in preparation for colonoscopy.

View full patent landscape →
11 OB patents · 2 families · 186 international docs across 37 countries

PLENVU Patents & Exclusivity

Latest Patent: Sep 2033

Patents (11 active)

US9326969 Expires Sep 10, 2033
US10918723 Expires Sep 10, 2033
US12083179 Expires Sep 10, 2033
US10016504 Expires Sep 10, 2033
US9707297 Expires Sep 10, 2033
US8999313 Expires Sep 10, 2033
US9592252 Expires Aug 11, 2032
US10646512 Expires Mar 25, 2032
US11529368 Expires Mar 9, 2032
US10792306 Expires Mar 9, 2032
US10780112 Expires Mar 9, 2032
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for PLENVU

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2033
  • • 11 active patents

Trial Analysis

  • • 3 total trials
  • • Stage: Expansion

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA209381 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment