Galzin

(Zinc)

ApprovedSmall molecule

AAmerican Regent, Inc.

Galzin is one of 148 small molecule programs targeting Malnutrition. It is currently in Approved.

Indications

Total Trials

Active Trials

147

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MalnutritionActive, not recruiting

MortalityActive, not recruiting

NephropathyActive, not recruiting

TeratozoospermiaUnknown status

MucositisCompleted

Gastroesophageal Reflux DiseaseNot yet recruiting

Idiopathic Pulmonary FibrosisRecruiting

MalnutritionPreclinical

Active, not recruiting

MortalityPreclinical

Active, not recruiting

NephropathyPreclinical

Active, not recruiting

TeratozoospermiaPreclinical

Unknown status

MucositisApproved

Completed

Gastroesophageal Reflux DiseaseApproved

Not yet recruiting

Idiopathic Pulmonary FibrosisPhase 2

Recruiting

Competition

Competitive Landscape

49 competitors in Mortality

#DrugCompanyPhaseTrials

Zithromax

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

10 2

Lovenox

Sanofi

Approved

1 3

Aldactone

Pfizer

Approved

1 4

Coly-Mycin M

PParkedale

Approved

2 5

Galzin

AAmerican Regent, Inc.

Approved

1 6

Merrem

BB. Braun Medical Inc.

Approved

1 7

Zocor

OOrganon and Co

Approved

1 8

Venofer

AAmerican Regent, Inc.

Approved

1 9

ZINPLAVA

Merck & Co.

Approved

1 10

Mounjaro

Eli Lilly

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Idiopathic Pulmonary Fibrosis

NCT06567717

Clinical

Trials by Indication[1]

COVID-195 trials

A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers

Unknown status·MMilitary Hospital of Tunis·Phase 3·NCT04377646·660 enrolled

Zinc With Chloroquine/Hydroxychloroquine in Treatment of COVID-19

Completed·TTanta University·Phase 3·NCT04447534·191 enrolled

The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19

Unknown status·MMinistry of Health, Saudi Arabia·Phase 4·NCT04468139·60 enrolled

Show 2 more trials

A Preventive Treatment for Migrant Workers at High-risk of COVID-19

Completed·NNational University Hospital, Singapore·Phase 3·NCT04446104·4,257 enrolled

Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients

Unknown status·SSohaib Ashraf·Phase 1/2·NCT04472585·180 enrolled

Pneumonia5 trials

Therapeutic Zinc in Childhood Pneumonia

Completed·CCentre For International Health·Phase 2/3·NCT00252304·641 enrolled

Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study

Completed·TTufts University·Phase 4·NCT00228254·2,582 enrolled

Efficacy of Zinc in the Treatment of Pneumonia

Completed·JJohns Hopkins Bloomberg School of Public Health·N/A·NCT00198666·299 enrolled

Show 2 more trials

CHIZAP: Community- and Health Facility-Based Intervention With Zinc as Adjuvant Therapy for Childhood Pneumonia

Completed·CCentre For International Health·Phase 2/3·NCT00148733·2,628 enrolled

Zinc and Pneumonia Protocol

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00133432·600 enrolled

Diarrhoea2 trials

Immunological and Clinical Responses to Zinc in Children With Diarrhoea

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 3·NCT00408356·338 enrolled

Efficacy of Zinc Therapy in Acute Diarrhoea in Young Children

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 3·NCT00325247·2,050 enrolled

Diarrhea2 trials

Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces Boulardii in Acute Watery Diarrhea in Paediatric Patients

Completed·RRESnTEC, Institute of Research·N/A·NCT06540209·60 enrolled

Long-term Impact and Intervention for Diarrhea in Brazil

Unknown status·UUniversity of Virginia·Phase 3·NCT00133406·321 enrolled

Diabetes Mellitus1 trial

Zinc Supplementation in Patients With β-Thalassemia Major Complicated With Diabetes Mellitus

Completed·—·Phase 3·NCT03851055·80 enrolled

22 more indications

Prevention1 trial

The CRISIS Prevention Study

Terminated·MMichael Dean·Phase 3·NCT00395161·293 enrolled

Randomized1 trial

Randomized Placebo-Controlled Trial (RPCT) of Maize/Zinc in Guatemala

Completed·NNICHD Global Network for Women's and Children's Health·Phase 3·NCT00098202·420 enrolled

Mucositis1 trial

Oral Zinc Therapy for the Prevention of Mucositis

Completed·SSheba Medical Center·Phase 4·NCT00449592·40 enrolled

Nephropathy1 trial

Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn

Terminated·RRobert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)·N/A·NCT00399256·60 enrolled

Fibrosis1 trial

Zinc Sulphate in Treatment Fibrosis in HBV Patient Receiving Antiviral Therapy

Not yet recruiting·TTanta University·Phase 2·NCT07145268·44 enrolled

Genital Warts1 trial

A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts

Terminated·UUniversity of British Columbia·Phase 4·NCT01468636·50 enrolled

Children1 trial

A Trial of Zinc and Micronutrients in Tanzanian Children

Completed·HHarvard School of Public Health (HSPH)·Phase 3·NCT00421668·2,400 enrolled

Mortality1 trial

Impact of Zinc Supplementation in Low Birth Weight Infants on Severe Morbidity, Mortality and Zinc Status: A Randomized Controlled Trial

Completed·SSociety for Applied Studies·N/A·NCT00272142·2,000 enrolled

Pediatric Patients1 trial

Effect of Probiotic and Zinc Supplementations on the Clinical Outcome in Pediatric Patients with Ventriculitis

Recruiting·—·Phase 4·NCT06151392·140 enrolled

Preterm Delivery1 trial

The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β

Completed·IIndonesia University·Phase 4·NCT03005496·56 enrolled

Idiopathic Pulmonary Fibrosis1 trial

Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis

Recruiting·—·Phase 2·NCT06567717·60 enrolled

Tinnitus1 trial

Zinc to Treat Tinnitus in the Elderly

Completed·UUniversity of Iowa·Phase 2·NCT00683644·116 enrolled

Acute Diarrhea1 trial

Impact of Home Zinc Treatment for Acute Diarrhea in Children

Completed·CCenters for Disease Control and Prevention·Phase 3·NCT00530829·3,000 enrolled

Pulmonary Tuberculosis1 trial

Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis

Completed·—·Phase 3·NCT00801606·403 enrolled

Teratozoospermia1 trial

Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia

Unknown status·—·N/A·NCT05156684·140 enrolled

Gastroesophageal Reflux Disease1 trial

The Effect of Probiotic and Zinc Supplementation in Patients With Gastroesophageal Reflux Disease

Not yet recruiting·—·Phase 4·NCT06664008·120 enrolled

Malnutrition1 trial

Package of Interventions After Recovering From Moderate Acute Malnutrition

Completed·WWashington University School of Medicine·N/A·NCT02351687·1,499 enrolled

Head and Neck Cancer1 trial

A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

Completed·BBrooklyn ImmunoTherapeutics, LLC·Phase 2·NCT00210470·27 enrolled

Respiratory Infections1 trial

Role of Zinc in Recurrent Acute Lower Respiratory Infections

Completed·—·Phase 3·NCT00536133·208 enrolled

AIN1 trial

Zinc Containing Vaginal Topical " Suppository "

Completed·EEgymedicalpedia·Phase 1/2·NCT05453227·50 enrolled

Cholera1 trial

Zinc Supplementation in Cholera Patients

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 3·NCT00226616

Unspecified1 trial

A Novel Bio-marker of Zinc Status

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 1·NCT01062347

Regulatory

FDA Approval Timeline[4]

Jun 26, 1986

ZINC CHLORIDE IN PLASTIC CONTAINER

NDA NDA018959

May 5, 1987

ZINC SULFATE

NDA NDA019229

Jan 28, 1997

GALZIN

NDA NDA020458

Apr 15, 2020

ZINC SULFATE

NDA NDA209377

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for Zinc. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zinc compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zinc. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209377). U.S. Food & Drug Administration.
[5]
SEC EDGAR — American Regent, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAmerican Regent, Inc.

Galzin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

COVID-195 trials

Pneumonia5 trials

Diarrhoea2 trials

Diarrhea2 trials

Diabetes Mellitus1 trial

Prevention1 trial

Randomized1 trial

Mucositis1 trial

Nephropathy1 trial

Fibrosis1 trial

Genital Warts1 trial

Children1 trial

Mortality1 trial

Pediatric Patients1 trial

Preterm Delivery1 trial

Idiopathic Pulmonary Fibrosis1 trial

Tinnitus1 trial

Acute Diarrhea1 trial

Pulmonary Tuberculosis1 trial

Teratozoospermia1 trial

Gastroesophageal Reflux Disease1 trial

Malnutrition1 trial

Head and Neck Cancer1 trial

Respiratory Infections1 trial

AIN1 trial

Cholera1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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