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Data updated: May 26, 2026

COLPREP KIT (magnesium sulfate)

Gastrointestinal Approved 2016-12-27
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Discontinued
First Approved
2016-12-27
Routes
ORAL
Dosage Forms
POWDER

Companies

GATOR PHARMS
Active Ingredient: MAGNESIUM SULFATE , POTASSIUM SULFATE , SODIUM SULFATE

COLPREP KIT Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2016 to 2016
Dec 2016 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What COLPREP KIT Treats

1 FDA approvals

Originally approved for its first indication in 2016 .

  • Other (1)
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Clinical Trial Registry

96 trials
Trial Sponsor ID Phase Status Title
NCT04740294 20.1171 Ph 2, Ph 3 withdrawn Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis
NCT04938765 5210244 Ph 4 recruiting Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring
NCT06811233 2024-1369 NCI-2025-00860, CDMRP-TX230317 Ph 2 recruiting Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study
NCT07524972 Suez Canal-MD-2025 Ph 3 recruiting Antenatal Magnesium Sulphate in High-Risk Preterm Patients
NCT06455514 20-00262 1R34HL166859-01A1 Ph 1 recruiting Post-CA Neuroprotection With Magnesium
NCT06513013 TAP in cs using us Ph 2, Ph 3 completed MgSO4 as Adjuvants to Bupivacaine vs Neostigmine in TAP Block in Cesarean Section
NCT07478055 108288 Ph 4 not yet recruiting Biomarkers in Management of Post Partum Preeclampsia
NCT06477133 24-00463 Ph 4 active not recruiting Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery
NCT07443163 MD-313-2025 Ph 3 not yet recruiting Comparison Between Total Intravenous Anesthesia With Magnesium Sulphate Versus Total Intravenous Anesthesia With Dexmedetomidine in Patients Undergoing Lumbar Spine Surgeries
NCT04275661 ESPB in breast cancer surgery Ph 2 completed Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery
NCT06785272 MAGICIAN 5274 Ph 3 recruiting Magnesium Trial in Acute Asthma in Emergency Department
NCT05730816 MAGIC-AKI 2023p000276 K23DK125672 Ph 2 recruiting MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI
NCT07220902 LEVMag 1559 Ph 3 not yet recruiting Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure
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
NCT03925025 CCBOC AC19003 Ph 3 completed Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning
NCT05829317 ATOMIC ATOMIC Ph 4 recruiting Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients
NCT07126795 HCMC Pediatric Burn Study Ph 1 not yet recruiting Magnesium Sulfate in Pediatric Burn Dressing Changes
NCT06745388 2024-115 Ph 4 recruiting Magnesium and Cramping
NCT07131033 CLanXie Ph 1, Ph 2 active not recruiting Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy
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
NCT06956521 H-50731 Ph 1 not yet recruiting Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke
NCT06955559 Mg bronchialasthma bronchiolis Ph 3 not yet recruiting Magnesium Sulfate in Bronchial Asthma and Acute Bronchiolitis in Children
NCT06920576 CLXie Ph 1, Ph 2 active not recruiting Effects of Esketamine Versus Magnesium Sulfate on Emotional State and Postoperative Pain in Patients Undergoing Nasal Endoscopic Surgery
NCT06848595 mg/dex/rSO2 36265MD317/11/24 Ph 3 not yet recruiting Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation
NCT06414356 954942 Ph 4 recruiting The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD
NCT05554848 N-62-2022 Ph 4 completed Dexmedetomidine and Magnesium Sulfate in Preventing Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery
NCT06026527 MagSulf1234 Ph 3 completed Intra-operative Magnesium Sulphate for Post-operative Pain in Patients Undergoing Total Abdominal Hysterectomy Under General Anesthesia
NCT04898114 Neb-Mag-2 Ph 1, Ph 2 recruiting Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
NCT04812028 results posted PEDS-2019-27677 Ph 2 completed Magnesium Sulfate for Analgesia in Pediatric Transplant
NCT01950520 results posted 130200 13-DK-0200 Ph 2 completed Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
NCT05967442 MAGraine results posted AHC-7192-D5000322 Ph 3 completed Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines
NCT05855798 esp01 Ph 4 completed Ketamine and Magnesium in Erector Spinae Plane Block
NCT06578000 Iontophoresis P.T.REC/012/004798 Ph 1 recruiting Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients
NCT05669417 POMPAE T-21-118 Ph 2, Ph 3 terminated Peri-Operative Magnesium Infusion to Prevent Atrial Fibrillation Evaluated.
NCT05671081 FMASU R263/2022 Ph 3 completed Dexmedetomidine Versus Magnesium Sulfate in Ultrasound Guided Bilateral Bi-level Erector Spinae Plane Block in Corrective Scoliosis Surgery
NCT06367595 Intrathecal MgSO4 Ph 2 not yet recruiting Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy
NCT04638881 MgPOEM results posted 58859 Ph 2 completed Magnesium for Peroral Endoscopic Myotomy
NCT05261516 Volmag 2019-02104/CE3541 Ph 4 recruiting Interaction of Volatile Anesthetics With Magnesium
NCT05565664 MD-60-2022 Ph 4 completed Ketamine Versus Magnesium as Analgesic Adjuvants in Pediatric Adenotonsillectomy
NCT05325580 Emergency Monastir Ph 3 recruiting Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
NCT05858957 Extubation quality Ph 4 completed Magnesium Sulphate and Extubation Quality
NCT04330755 MD-223-2019 Ph 4 completed Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy
NCT03208452 B1605/346-002 Ph 4 completed The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation
NCT05880693 Sameh Ph 1 completed Comparisons Between Dexmedetomidine and Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries
NCT05850832 0305810 Ph 2, Ph 3 completed Efficacy of Esmolol Versus Magnesium Sulphate on Quality of Recovery in Patients Undergoing Laparoscopic Cholecystectomy: Randomized Controlled Study
NCT03497923 MagNeoSug CCER 2016-00018 Ph 4 completed Interaction Between Magnesium and Neostigmine or Sugammadex for the Reversal of a Rocuronium-induced Neuromuscular Block
NCT02680626 ANAE-275-15 Ph 4 terminated Bilateral Transversus Abdominis Plane Block With or Without Magnesium
NCT04300985 CAAE 28455419.9.0000.5448 Ph 3 completed Magnesium Sulfate Versus Dexmedetomidine on Anesthesia Awakening.
NCT01099449 results posted N08CB NCCTG-N08CB, CDR0000669660 Ph 3 completed Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy
NCT04554862 M419 Ph 4 completed The Analgesic Efficacy of Magnesium and Ketorolac in Ultrasound Supraclavicular Block

Showing 50 of 96 trials

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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.

COLPREP KIT FDA Label Details

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Data Sources

FDA Approval: NDA204553 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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