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Alinia

(Nitazoxanide)

ApprovedSmall molecule

RRomark Laboratories L.C.

Nitazoxanide is used to treat infections caused by parasites and certain bacteria, particularly diarrheal infections caused by specific parasites like Cryptosporidium and Giardia.[2] Alinia is currently approved and in use across 34 indications[4].[1]

Alinia is one of 743 small molecule programs targeting HIV infection. It is currently in Approved.

34

Indications

86

Total Trials

9

Active Trials

742

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionApproved

ColitisActive, not recruiting

Respiratory System DiseaseApproved

Sexually Transmitted DiseaseApproved

BronchiolitisActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

Kidney DiseaseApproved

Chronic HepatitisActive, not recruiting

Clostridium Difficile InfectionActive, not recruiting

Pseudomembranous EnterocolitisApproved

HIV InfectionApproved

Approved

ColitisPhase 2

Active, not recruiting

Respiratory System DiseaseApproved

Approved

Sexually Transmitted DiseaseApproved

Approved

BronchiolitisPhase 2

Active, not recruiting

Type 2 Diabetes MellitusPhase 2

Active, not recruiting

Kidney DiseaseApproved

Approved

Chronic HepatitisPhase 2/Phase 3

Active, not recruiting

Clostridium Difficile InfectionPhase 3

Active, not recruiting

Pseudomembranous EnterocolitisApproved

Approved

Showing 10 of 33 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Alinia

RRomark Laboratories L.C.

Spikevax

Bnt162b2

COVID-19 Vaccine

Biaxin

Singulair

Stivarga

Aimovig

Aldactone

Nexavar

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

Timeline

Expected Milestones

Q3 2026

Phase 1/2Recruiting

COVID-19

NCT04746183

Q4 2026

Phase 2Recruiting

Ulcerative Colitis

NCT06993974

Q1 2027

Phase 2Recruiting

COVID-19

NCT05041907

Q2 2028

Phase 2/3Not yet recruiting

Combination Therapy

NCT05897034

Clinical

Trials by Indication[1]

COVID-1922 trials

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

Terminated·RRomark Laboratories L.C.·Phase 3·NCT04343248·190 enrolled

Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

Recruiting·UUniversity of Oxford·Phase 2·NCT05041907·3,800 enrolled

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

Completed·RRomark Laboratories L.C.·Phase 3·NCT04486313·935 enrolled

Show 19 more trials

Catalysing the Containment of COVID-19

Terminated·UUniversity of Cape Town·Phase 2/3·NCT04523090·322 enrolled

Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients

Withdrawn·AAzidus Brasil·Phase 2/3·NCT04441398

Favipiravir +/- Nitazoxanide: Early Antivirals Combination Therapy in COVID-19

Completed·CCoordinación de Investigación en Salud, Mexico·Phase 2·NCT04918927·120 enrolled

Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts

Unknown status·FFundación Huésped·Phase 4·NCT04788407·456 enrolled

Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19

Completed·—·Phase 4·NCT04498936·240 enrolled

Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19

Withdrawn·AAzidus Brasil·Phase 2·NCT04435314

Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19

Unknown status·AAzidus Brasil·Phase 3·NCT04423861·380 enrolled

Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness

Withdrawn·RRomark Laboratories L.C.·Phase 3·NCT05157269

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

Completed·RRomark Laboratories L.C.·Phase 3·NCT04359680·1,407 enrolled

Effects of Early Use of Nitazoxanide in Patients With COVID-19

Completed·UUniversidade Federal do Rio de Janeiro·Phase 2·NCT04552483·392 enrolled

Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19)

Unknown status·LLaboratorios Roemmers S.A.I.C.F.·Phase 2/3·NCT04463264·135 enrolled

COVID-19 Prophylaxis South Africa (COVER HCW)

Completed·UUniversity of Witwatersrand, South Africa·Phase 2·NCT04561063·1,950 enrolled

A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19

Terminated·RRutgers, The State University of New Jersey·Phase 2·NCT04605588·7 enrolled

Novel Regimens in COVID-19 Treatment

Recruiting·TTanta University·Phase 3·NCT04382846·160 enrolled

AGILE (Early Phase Platform Trial for COVID-19)

Recruiting·UUniversity of Liverpool·Phase 1/2·NCT04746183·600 enrolled

Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness

Withdrawn·RRomark Laboratories L.C.·Phase 3·NCT05157243

Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19

Completed·AAzidus Brasil·N/A·NCT04348409·50 enrolled

Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19

Terminated·HHugo Mendieta Zeron·Phase 4·NCT04341493·44 enrolled

Prevention of Coronavirus Disease (COVID-19) Outbreaks With Nitazoxanide

Completed·MMaterno-Perinatal Hospital of the State of Mexico·Phase 4·NCT04406246·150 enrolled

Chronic Hepatitis6 trials

Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

Completed·RRomark Laboratories L.C.·Phase 2·NCT00418639·50 enrolled

4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C

Completed·RRomark Laboratories L.C.·Phase 2·NCT00763568·40 enrolled

Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

Completed·RRomark Laboratories L.C.·Phase 2/3·NCT00421434·121 enrolled

Show 3 more trials

Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients

Completed·NNational Liver Institute, Egypt·Phase 2/3·NCT01197157·200 enrolled

Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B

Completed·RRomark Laboratories L.C.·Phase 2·NCT03905655·51 enrolled

Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)

Completed·—·Phase 2/3·NCT01276756·100 enrolled

Influenza5 trials

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

Completed·RRomark Laboratories L.C.·Phase 2/3·NCT01227421·624 enrolled

Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

Terminated·RRomark Laboratories L.C.·Phase 2·NCT01056380·79 enrolled

A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza

Completed·RRomark Laboratories L.C.·Phase 3·NCT03336619·1,030 enrolled

Show 2 more trials

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

Completed·RRomark Laboratories L.C.·Phase 3·NCT01610245·1,941 enrolled

Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

Completed·RRomark Laboratories L.C.·Phase 3·NCT02612922·325 enrolled

Hepatitis C5 trials

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients

Completed·RRomark Laboratories L.C.·Phase 2·NCT00637923·112 enrolled

Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C

Completed·RRomark Laboratories L.C.·Phase 2·NCT00418054·40 enrolled

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

Completed·RRomark Laboratories L.C.·Phase 2·NCT00495391·64 enrolled

Show 2 more trials

A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation

Completed·MMayo Clinic·Phase 1·NCT01074203·8 enrolled

The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients

Completed·SServices Institute of Medical Sciences, Pakistan·Phase 4·NCT01770483·66 enrolled

Diarrhea4 trials

Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

Completed·RRomark Laboratories L.C.·Phase 3·NCT01326338·100 enrolled

A Study of Nitazoxanide in Patients With AIDS and Diarrhea Caused by Cryptosporidium

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001081·60 enrolled

A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea

Completed·UUnimed Pharmaceuticals·Phase 1·NCT00002444·28 enrolled

Show 1 more trial

Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00055107·6 enrolled

31 more indications

Encephalopathy4 trials

Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Completed·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·N/A·NCT01135628·60 enrolled

Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Recruiting·TTanta University·Phase 3·NCT04161053·60 enrolled

The Effects of Nitazoxanide in Hepatic Encephalopathy

Unknown status·—·Phase 2·NCT02334163·36 enrolled

Show 1 more trial

Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

Unknown status·SSherief Abd-Elsalam·Phase 2/3·NCT02464124·120 enrolled

Cryptosporidiosis3 trials

A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis

Unknown status·RRomark Laboratories L.C.·N/A·NCT00002158

Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients

Terminated·RRomark Laboratories L.C.·Phase 3·NCT00004986·30 enrolled

Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh

Not yet recruiting·JJohns Hopkins Bloomberg School of Public Health·Phase 3·NCT06600711·480 enrolled

Treatment3 trials

Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

Completed·RRomark Laboratories L.C.·Phase 2·NCT01328925·100 enrolled

Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02057757·260 enrolled

Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00991289·68 enrolled

Rhinovirus Infection2 trials

Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

Completed·RRomark Laboratories L.C.·Phase 3·NCT03605862·1,756 enrolled

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

Terminated·RRomark Laboratories L.C.·Phase 3·NCT04489381·214 enrolled

Ulcerative Colitis2 trials

Nitazoxanide in Patients With Ulcerative Colitis

Recruiting·—·Phase 2·NCT06993974·70 enrolled

Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis

Unknown status·RResearch Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan·Phase 1/2·NCT03441893·300 enrolled

Helicobacter Pylori2 trials

Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children

Recruiting·TTanta University·Phase 3·NCT04415983·100 enrolled

Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori

Unknown status·SSherief Abd-Elsalam·Phase 3·NCT02422706·120 enrolled

MPA2 trials

Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients

Completed·GGenfit·Phase 1·NCT05116826·25 enrolled

Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects

Completed·GGenfit·Phase 1·NCT05368935·77 enrolled

Irritable Bowel Syndrome2 trials

Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

Completed·AAmerican Academy of Family Physicians·Phase 4·NCT01641341·61 enrolled

Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation

Withdrawn·SSadat City University·Phase 1/2·NCT05453916

Amebiasis2 trials

Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents

Completed·RRomark Laboratories L.C.·Phase 3·NCT00366236·50 enrolled

Study of Nitazoxanide in the Treatment of Amebiasis in Children

Completed·RRomark Laboratories L.C.·Phase 3·NCT00366730·50 enrolled

Pneumonia1 trial

Nitazoxanide Therapy for Patients With COVID-19 Pneumonia

Completed·UUniversidade Federal do Rio de Janeiro·Phase 2·NCT04561219·500 enrolled

Tuberculosis1 trial

A 14 Day Early Bactericidal Activity Study of Nitazoxanide for the Treatment of Tuberculosis

Completed·WWeill Medical College of Cornell University·Phase 2·NCT02684240·30 enrolled

Clostridium Difficile1 trial

Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

Terminated·RRomark Laboratories L.C.·Phase 3·NCT00384527·50 enrolled

Type 2 Diabetes Mellitus1 trial

Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus

Unknown status·TTanta University·Phase 2·NCT06010992·70 enrolled

Peritonitis1 trial

Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis

Unknown status·TTanta University·Phase 3·NCT04746937·60 enrolled

HIV Coinfection1 trial

Efficacy of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in HCV Genotype 4 and HIV Coinfection

Unknown status·JJuan Macías·Phase 2·NCT01529073·45 enrolled

Trial1 trial

EAT-DUTA AndroCoV Trial

Completed·CCorpometria Institute·Phase 2/3·NCT04729491·138 enrolled

Children1 trial

Efficacy of Nitazoxanide Based Therapy vs Standard Triple Therapy in H-pylori in Children

Completed·MMuhammad Aamir Latif·N/A·NCT07086937·66 enrolled

Prophylaxis1 trial

Comparative Study of Secondary Prophylaxis for SBP

Completed·TTanta University·Phase 4·NCT06827756·90 enrolled

Interaction1 trial

Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers

Completed·OObafemi Awolowo University·N/A·NCT05680792·17 enrolled

Gastroenteritis1 trial

Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children

Terminated·TTelethon Kids Institute·Phase 2/3·NCT02165813·216 enrolled

Clostridium Difficile Infection1 trial

Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection

Completed·—·Phase 3·NCT00304356·22 enrolled

Acute Diarrhea1 trial

Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

Completed·CCentro Pediatrico Albina de Patino·N/A·NCT00683982·75 enrolled

Bronchiolitis1 trial

Finding Better Treatment of Bronchiolitis: A Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments

Withdrawn·TTelethon Kids Institute·Phase 2·NCT02452905

Metastatic Colorectal Cancer1 trial

Nitazoxanide in Patients With Metastatic Colorectal Cancer

Recruiting·TTanta University·Phase 3·NCT06049901·60 enrolled

Virus1 trial

NNITS-Nitazoxanide for Norovirus in Transplant Patients Study

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03395405·31 enrolled

Crohn's Disease1 trial

Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease

Terminated·RRomark Laboratories L.C.·Phase 2·NCT00130390·98 enrolled

Colitis1 trial

Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Completed·RRomark Laboratories L.C.·Phase 2·NCT00417872·114 enrolled

Rheumatoid Arthritis1 trial

Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis

Completed·TTanta University·Phase 3·NCT05480878·90 enrolled

Combination Therapy1 trial

Combination Therapy Between Doxycycline, Pentoxifylline, and Nitazoxanide in Sexually Active Men

Not yet recruiting·TTanta University·Phase 2/3·NCT05897034·100 enrolled

Growth1 trial

Early Life Interventions for Childhood Growth and Development In Tanzania

Completed·HHaydom Lutheran Hospital·Phase 2/3·NCT03268902·1,188 enrolled

Unspecified1 trial

A Two Week Nitazoxanidebased Quadruple Regimen

Unknown status·TTanta University·Phase 3·NCT02621359·100 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 22, 2002

ALINIA

NDA NDA021498

Jul 21, 2004

ALINIA

NDA NDA021497

Sources

References

[1]
ClinicalTrials.gov — 86 trial records for Nitazoxanide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Alinia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nitazoxanide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nitazoxanide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021497). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Romark Laboratories L.C. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Pyruvate:ferredoxin Oxidoreductase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: RRomark Laboratories L.C.

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