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Data updated: May 26, 2026

SOLUPREP S (chlorhexidine gluconate)

Infectious Disease Approved 2018-08-08
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
Over-the-counter
First Approved
2018-08-08
Patent Cliff
2026

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Routes
TOPICAL
Dosage Forms
SOLUTION

Companies

SOLVENTUM
Active Ingredient: CHLORHEXIDINE GLUCONATE , ISOPROPYL ALCOHOL

SOLUPREP S Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2018 to 2023 · 1 indication expansions
Jan 2023 SUPPL
Efficacy
FDA Letter Label
Aug 2018 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What SOLUPREP S Treats

2 FDA approvals

Originally approved for its first indication in 2018 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

31 trials
Trial Sponsor ID Phase Status Title
NCT06587880 224000195 284/2023-2024 Ph 4 recruiting The Effect of Different Types of Mouthwash on Extraction Sockets' Healing
NCT03489629 STAR-TER 17-2144 Ph 2 completed STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)
NCT05110001 REAGIR results posted 18-26045-R UG1EY028518 Ph 3 completed Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
NCT03140254 results posted MPS-16IPVAW01 Ph 2 completed Evaluating Safety and Effectiveness of Octenidine Dihydrochloride
NCT06733506 2018-0488 Ph 4 completed A Pilot Study to Evaluate Skin Swabbing With Chlorhexidine to Prevent Skin And Soft Tissue Infections Among People Who Inject Drugs
NCT06126614 PREVENT-iT PiT-2023 Ph 3 recruiting Infection Prophylaxis in Total Joint Replacement
NCT03331263 results posted R17-023 Ph 1 completed Single Dose CHG Pharmacokinetic Study
NCT06144983 417121 Ph 4 completed Chlorhexidine Gel Versus Alvogyl Following Surgical Extraction of Impacted Mandibular Third Molar
NCT04021524 results posted STUDY00005028 Ph 4 completed BPO vs Hibiclens Soap for Surgical Preparation
NCT02326467 results posted IRB-P00011128 Ph 1 completed Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
NCT02222896 results posted R13-053 Ph 3 completed Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects
NCT02291601 results posted R13-052 Ph 3 completed Preoperative CHG Cloth on Healthy Subjects
NCT04654182 #2007591-102 Ph 4 completed Evaluation of the Residual Antimicrobial Efficacy of One Test Material Based on a Modification of ASTM E1115-11 Test Method
NCT02589067 results posted 30529 Ph 2 completed Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization
NCT02526667 results posted R15-029 Ph 3 completed Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers
NCT02943759 Chx_neemleaf Ph 2, Ph 3 completed Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy
NCT03133312 VAGPrep Ph 4 completed Chlorhexidine Gluconate Versus Povidone-Iodine as Vaginal Preparation Antiseptics Prior to Cesarean Delivery
NCT03372122 #170104-150 Ph 4 completed Removal of Bacterial Spores in Adults on Skin
NCT01537783 results posted ED Staph Eradication Ph 4 completed Evaluation of a Staphylococcus Eradication Protocol for Patients Who Present to the ED With Cutaneous Abscess
NCT01495117 CHG NCCCTS-11-563 Ph 3 completed Study of Chlorhexidine Gluconate as a Preoperative Antisepsis
NCT02639377 UFRN-2 Ph 2 completed Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis
NCT02605382 UFRN Ph 2 completed Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis
NCT01613365 CHLORHEX 2011-004536-63 2011-24 Ph 3 completed Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections
NCT02446158 EDAHP99020 Ph 4 completed Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients
NCT02433899 CEP CMM/HUAP no 162/2010 Ph 4 completed Microsurgical Versus Conventional Semilunar Coronally Advanced Flap
NCT02337192 orto14 Ph 1 completed Antimicrobial Photodynamic Therapy Applied in Orthodontic. Orthodontic Patients.
NCT01857804 olivier1 Ph 4 completed Surgical Treatment of Peri-implantitis
NCT02154594 DHANASHREE289 Ph 4 completed "The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.
NCT01782573 CCH - 110801 Ph 4 completed The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients
NCT00759187 results posted CRO-0607-PLA-11-RR Ph 3 completed Evaluate Clinical Research From Commerical Oral Care Products
NCT01024738 results posted CRO-2008-PLA-05-RR Ph 3 completed Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
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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.

SOLUPREP S FDA Label Details

SOLUPREP S Patents & Exclusivity

Exclusivity: Jan 2026

Exclusivity

M-292 Until Jan 2026
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA208288 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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