Nitazoxanide

Summary

Nitazoxanide (CHEMBL1401) is an approved small molecule (ATC P01AX11); indicated across 29 conditions including diarrheal disease and amebiasis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: P01AX11
• Indications: 29 conditions
• Clinical trials: 85
• Chemistry: 307.28 Da · C12H9N3O5S

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1401
Name	Nitazoxanide
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	41684
ATC	P01AX11
Molecular formula	C12H9N3O5S
Molecular weight	307.28
InChIKey	YQNQNVDNTFHQSW-UHFFFAOYSA-N

SMILES: CC(=O)OC1=CC=CC=C1C(=O)NC2=NC=C(S2)[N+](=O)[O-]

IUPAC name: [2-[(5-nitro-1,3-thiazol-2-yl)carbamoyl]phenyl] acetate

Also known as: Alinia, Nitazoxanida, Nitazoxanide, NSC-697855, NSC-760057, PH 5776, PH-5776, nitazoxanide, SID17388853, SID26719875, SID49681590, NITAZOXANIDE

Patent coverage: 2,652 distinct patent families (9,504 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 9,483 (100%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 67 (assay-derived). Sample: Pyruvate kinase PKM, Microtubule-associated protein tau, Nuclear receptor ROR-gamma, Survival motor neuron protein, Fructose-bisphosphate aldolase, Prelamin-A/C, 4’-phosphopantetheinyl transferase ffp, NPC intracellular cholesterol transporter 1, Ras-related protein Rab-9A, Vasopressin V2 receptor.

Bioactivity

ChEMBL activities: 45 potent at pChembl ≥ 5 of 77 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
Q63921	8.51	AC50	3.1	nM	CHEMBL_ACT_25174400
PTGS1	7.94	AC50	11.4	nM	CHEMBL_ACT_25205348
ANO1	6.37	IC50	424	nM	CHEMBL_ACT_24761135
HTR2C	6.35	AC50	450	nM	CHEMBL_ACT_25131810
RAB9A	6.3	Potency	501.2	nM	CHEMBL_ACT_3859408
NPC1	6.3	Potency	501.2	nM	CHEMBL_ACT_4728295
HDAC6	6	IC50	1011	nM	CHEMBL_ACT_23141047
P15917	5.9	Potency	1259	nM	CHEMBL_ACT_4663667
CHRM2	5.85	AC50	1400	nM	CHEMBL_ACT_25214944
SLC29A1	5.72	AC50	1900	nM	CHEMBL_ACT_25141540
P51450	5.55	Potency	2818	nM	CHEMBL_ACT_4073039
HTR3A	5.51	AC50	3100	nM	CHEMBL_ACT_25149126
NPSR1	5.5	Potency	3162	nM	CHEMBL_ACT_4884764
CHRM1	5.36	AC50	4334	nM	CHEMBL_ACT_25210318
BDKRB2	5.31	AC50	4900	nM	CHEMBL_ACT_25170454
ADORA3	5.3	AC50	5000	nM	CHEMBL_ACT_25134213
OPRD1	5.3	AC50	5000	nM	CHEMBL_ACT_25154071
TBXA2R	5.3	AC50	5000	nM	CHEMBL_ACT_25155205
TSHR	5.3	Potency	5012	nM	CHEMBL_ACT_3916307
TSHR	5.3	Potency	5012	nM	CHEMBL_ACT_4751113
SLC6A2	5.29	AC50	5100	nM	CHEMBL_ACT_25145004
AGTR1	5.25	AC50	5600	nM	CHEMBL_ACT_25176993
SLC6A4	5.2	AC50	6300	nM	CHEMBL_ACT_25150338
CCKAR	5.18	AC50	6600	nM	CHEMBL_ACT_25178209
ADORA1	5.15	AC50	7100	nM	CHEMBL_ACT_25133010
SLC6A3	5.14	AC50	7300	nM	CHEMBL_ACT_25123954
MAOA	5.12	AC50	7500	nM	CHEMBL_ACT_25159683
ADRB2	5.11	AC50	7800	nM	CHEMBL_ACT_25122871
ADRA2B	5.1	AC50	8000	nM	CHEMBL_ACT_25143704
CYP3A4	5.1	Potency	7943	nM	CHEMBL_ACT_4969664

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

29 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
diarrheal disease	4	MONDO:0001673	HP:0002014
amebiasis	4	MONDO:0005644	EFO:0007144
Clostridium infectious disease	3	MONDO:0024388	EFO:1000874
Helicobacter pylori infectious disease	3	MONDO:0006781	EFO:1000961
Clostridium difficile colitis	3	MONDO:0000705	EFO:1001314
dyspepsia	3	MONDO:0002268	EFO:0008533
respiratory system disorder	3	MONDO:0005087	EFO:0000684
influenza	3	MONDO:0005812	EFO:0007328
brain disorder	3	MONDO:0005560	HP:0001298
cryptosporidiosis	3	MONDO:0015474	MONDO:0015474
severe acute respiratory syndrome	3	MONDO:0005091	EFO:0000694
infectious peritonitis	3	MONDO:0004522	EFO:0008588
rheumatoid arthritis	3	MONDO:0008383	EFO:0000685
Crohn disease	2	MONDO:0005011	EFO:0000384
hepatitis C virus infection	2	MONDO:0005231	EFO:0003047
bronchiolitis	2	MONDO:0002465	HP:0011950
gastroenteritis	2	MONDO:0002269	EFO:1001463
chronic hepatitis C virus infection	2	MONDO:0005354	EFO:0004220
chronic hepatitis B virus infection	2	MONDO:0005366	EFO:0004239
periodontitis	2	MONDO:0005076	EFO:0000649
tuberculosis	2	MONDO:0018076	MONDO:0018076
sexually transmitted disease	2	MONDO:0021681	MONDO:0021681
type 2 diabetes mellitus	2	MONDO:0005148	MONDO:0005148
HIV infectious disease	1	MONDO:0005109	EFO:0000764
irritable bowel syndrome	1	MONDO:0005052	EFO:0000555
liver disorder	1	MONDO:0005154	EFO:0001421
kidney disorder	1	MONDO:0005240	EFO:0003086

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 85.

Phase distribution

Phase	Trials
PHASE2	27
PHASE3	25
PHASE2/PHASE3	13
Not specified	7
PHASE4	6
PHASE1	4
PHASE1/PHASE2	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01641341	PHASE4	COMPLETED	Irritable Bowel Syndrome Evaluation and Treatment in Primary Care
NCT01770483	PHASE4	COMPLETED	The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
NCT04341493	PHASE4	TERMINATED	Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19
NCT04498936	PHASE4	COMPLETED	Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19
NCT04788407	PHASE4	UNKNOWN	Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts
NCT06827756	PHASE4	COMPLETED	Comparative Study of Secondary Prophylaxis for SBP
NCT04161053	PHASE3	RECRUITING	Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
NCT04382846	PHASE3	RECRUITING	Novel Regimens in COVID-19 Treatment
NCT04415983	PHASE3	RECRUITING	Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children
NCT06600711	PHASE3	NOT_YET_RECRUITING	Nitazoxanide for Treatment of Cryptosporidium in Children
NCT00004986	PHASE3	TERMINATED	Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
NCT00302640	PHASE2/PHASE3	COMPLETED	Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
NCT00304356	PHASE3	COMPLETED	Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection
NCT00366236	PHASE3	COMPLETED	Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents
NCT00366730	PHASE3	COMPLETED	Study of Nitazoxanide in the Treatment of Amebiasis in Children
NCT00384527	PHASE3	TERMINATED	Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
NCT00421434	PHASE2/PHASE3	COMPLETED	Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C
NCT01197157	PHASE2/PHASE3	COMPLETED	Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients
NCT01227421	PHASE2/PHASE3	COMPLETED	Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
NCT01276756	PHASE2/PHASE3	COMPLETED	Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)
NCT01326338	PHASE3	COMPLETED	Nitazoxanide for the Treatment of Prolonged Diarrhea in Children
NCT01610245	PHASE3	COMPLETED	Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
NCT02165813	PHASE2/PHASE3	TERMINATED	Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children
NCT02422706	PHASE3	UNKNOWN	Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori
NCT02464124	PHASE2/PHASE3	UNKNOWN	Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy
NCT02612922	PHASE3	COMPLETED	Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
NCT02621359	PHASE3	UNKNOWN	A Two Week Nitazoxanidebased Quadruple Regimen
NCT03268902	PHASE2/PHASE3	COMPLETED	Early Life Interventions for Childhood Growth and Development In Tanzania
NCT03336619	PHASE3	COMPLETED	A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza
NCT03605862	PHASE3	COMPLETED	Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
NCT04343248	PHASE3	TERMINATED	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)
NCT04359680	PHASE3	COMPLETED	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
NCT04423861	PHASE3	UNKNOWN	Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19
NCT04441398	PHASE2/PHASE3	WITHDRAWN	Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients
NCT04463264	PHASE2/PHASE3	UNKNOWN	Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19)
NCT04486313	PHASE3	COMPLETED	Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
NCT04489381	PHASE3	TERMINATED	Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
NCT04523090	PHASE2/PHASE3	TERMINATED	Catalysing the Containment of COVID-19
NCT04729491	PHASE2/PHASE3	COMPLETED	EAT-DUTA AndroCoV Trial
NCT04746937	PHASE3	UNKNOWN	Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).