Ivadantin

(Nitrofurantoin)

ApprovedSmall molecule

PProcter and Gamble

Ivadantin is one of 148 small molecule programs targeting Osteomyelitis. 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

OsteomyelitisApproved

CystitisActive, not recruiting

Bacterial DiseaseActive, not recruiting

Urinary RetentionActive, not recruiting

Apical PeriodontitisRecruiting

Recurrent UtisRecruiting

FedCompleted

PregnancyTerminated

Urinary Tract InfectionCompleted

Antibiotic ProphylaxisRecruiting

OsteomyelitisApproved

Approved

CystitisApproved

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

Urinary RetentionApproved

Active, not recruiting

Apical PeriodontitisPhase 1

Recruiting

Recurrent UtisPhase 1

Recruiting

FedPreclinical

Completed

PregnancyPreclinical

Terminated

Urinary Tract InfectionApproved

Completed

Antibiotic ProphylaxisApproved

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

46 competitors in Pregnancy

#DrugCompanyPhaseTrials

Femara

Novartis

Approved

14 2

Bayer Aspirin

Bayer

Approved

8 3

Marinol

Jazz Pharmaceuticals

Approved

1 4

Rayos

RRoxane Laboratories

Approved

7 5

Ivadantin

PProcter and Gamble

Approved

1 6

Pifeltro

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

1 7

BEYFORTUS

Sanofi

Phase 3

1 8

Dihydroartemisinin-Piperaquine

GSK

Phase 3

4 9

Monoferric

PPharmacosmos A/S

Phase 3

1 10

Cimzia

UCB

Phase 2

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

Timeline

Expected Milestones

Q1 2027

N/ANot yet recruiting

Women

NCT07202832

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT06709196

Phase 1Recruiting

Apical Periodontitis

NCT07603934

Q4 2027

Post-ApprovalRecruiting

Urinary Tract Infection

NCT05652374

Q1 2029

Phase 1Recruiting

Recurrent Utis

NCT06907199

Clinical

Trials by Indication[1]

Urinary Tract Infection12 trials

Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study

Recruiting·RRadboud University Medical Center·Phase 4·NCT05652374·100 enrolled

Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections

Completed· GSK logo

GSK·Phase 1·NCT05138822·140 enrolled

Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women

Unknown status·UUniversity Hospital, Geneva·Phase 4·NCT01966653·600 enrolled

Show 9 more trials

A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)

Completed· GSK logo

GSK·Phase 3·NCT04020341·1,531 enrolled

Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery

Completed·WWake Forest University Health Sciences·Phase 4·NCT03287089·164 enrolled

A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)

Completed· GSK logo

GSK·Phase 3·NCT05630833·380 enrolled

Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)

Completed· GSK logo

GSK·Phase 3·NCT04187144·1,606 enrolled

Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence

Completed·UUniversity of Missouri-Columbia·Phase 4·NCT00734968·161 enrolled

Nitrofurantoin and Urinary Tract Infections (UTIs)

Terminated·UUniversity of Pittsburgh·N/A·NCT00678041·10 enrolled

Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI)

Completed·—·Phase 4·NCT01450800·163 enrolled

Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

Completed·RRoswell Park Cancer Institute·Phase 4·NCT04502095·89 enrolled

Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults

Completed·MMepha Ltd.·Phase 4·NCT01092351·37 enrolled

Cystitis5 trials

An Open Clinical Trial of the Safety and Efficacy of the Drug Fluorothiazinone, 300 Mg Tablets with the Participation of Adult Patients with Chronic Bacterial Cystitis"

Not yet recruiting·GGamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation·Phase 3·NCT06815549·280 enrolled

Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

Completed·PParatek Pharmaceuticals Inc·Phase 2·NCT03425396·225 enrolled

COMPARISON OF NITROFURANTOIN WITH FOSFOMYCIN in TREATING CYSTITIS IN WOMEN

Not yet recruiting·—·Phase 4·NCT06518291·392 enrolled

Show 2 more trials

EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care

Terminated·MMJM Bonten·Phase 3·NCT05254808·13 enrolled

Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis

Recruiting·MMahidol University·Phase 4·NCT07186465·100 enrolled

Antibiotics3 trials

Role of Prophylactic Postoperative Antibiotics in HoLEP

Withdrawn·—·Phase 4·NCT05274672

INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI

Withdrawn·MMayo Clinic·Phase 4·NCT03299387

The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy

Unknown status·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 1·NCT02789579·150 enrolled

Antibiotic Prophylaxis2 trials

Bladder Botox UTI Antibiotic Prophylaxis

Recruiting·WWalter Reed National Military Medical Center·Phase 4·NCT06387329·100 enrolled

Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

Recruiting·RRigshospitalet, Denmark·Phase 4·NCT06709196·248 enrolled

Intracanal Medicament2 trials

Effect of Nitrofurantion Used as an Intracanal Medicament

Unknown status·—·Phase 1·NCT05074628·38 enrolled

Comparison of Nitrofurantoin and Calcium Hydroxide as Intracanal Medicaments in Alleviating Post-operative Pain

Completed·—·Phase 4·NCT04900571·60 enrolled

12 more indications

Effectiveness2 trials

Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.

Completed·FFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina·Phase 4·NCT04959331·1,000 enrolled

The Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste

Completed·—·Phase 4·NCT05600023·60 enrolled

Women1 trial

Urine Alkalinization for UTI in Women: RCT

Not yet recruiting·—·N/A·NCT07202832·50 enrolled

Urinary retention1 trial

Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery

Completed·—·Phase 4·NCT02727322·154 enrolled

TED1 trial

Establish the Relationship Between Shift in Prescribing Pattern and Associated Shift in Sensitivity Pattern of Causative Microbes in UTI Patients in a Closed Community

Completed·—·Phase 4·NCT03716804·62 enrolled

Fed1 trial

Bioequivalence Study of Nitrofurantoin 100 mg Capsules Under Fed Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00778583·40 enrolled

Periodontitis1 trial

Comparison of Inter-appointment Pain Reduction During Root Canal Treatment in Symptomatic Apical Periodontitis by Using Intracanal Medicaments; Chlorhexidine Gel and Single Antibiotic Paste Nitrofurantoin

Enrolling by invitation·—·Phase 1/2·NCT07198919·220 enrolled

Congenital Abnormalities1 trial

Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract

Unknown status·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico·Phase 3·NCT02021006·292 enrolled

Recurrent Uti1 trial

Intravesical Gentamicin to Prevent Recurrent UTI

Recruiting·WWomen and Infants Hospital of Rhode Island·Phase 4·NCT06332781·30 enrolled

OnabotulinumtoxinA1 trial

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Recruiting·—·Phase 4·NCT05519072·140 enrolled

Pregnancy1 trial

Treatment of Asymptomatic Bacteriuria in Pregnancy

Terminated·TTrinity Health Michigan·N/A·NCT02911662·13 enrolled

Recurrent UTIs1 trial

A Multicentric Randomized Trial of Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for the Long-term Management of Cystitis in Women With Recurrent Urinary Tract Infections

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT06907199·104 enrolled

Apical Periodontitis1 trial

Evaluation of Postoperative Pain After Using Ibuprofen, Nitrofurantoin, or Calcium Hydroxide as Intracanal Medicaments in Root Canal Treatment of Necrotic Mandibular Posterior Teeth. A Randomized Controlled Trial

Recruiting·CCairo University·Phase 1·NCT07603934·111 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

IVADANTIN

NDA NDA012402

Jan 1, 1982

FURADANTIN

NDA NDA009175

Jan 1, 1982

FURADANTIN

NDA NDA008693

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for Nitrofurantoin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nitrofurantoin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nitrofurantoin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA012402). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Procter and Gamble company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: PProcter and Gamble

Ivadantin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q1 2029

Trials by Indication[1]

Urinary Tract Infection12 trials

Cystitis5 trials

Antibiotics3 trials

Antibiotic Prophylaxis2 trials

Intracanal Medicament2 trials

Effectiveness2 trials

Women1 trial

Urinary retention1 trial

TED1 trial

Fed1 trial

Periodontitis1 trial

Congenital Abnormalities1 trial

Recurrent Uti1 trial

OnabotulinumtoxinA1 trial

Pregnancy1 trial

Recurrent UTIs1 trial

Apical Periodontitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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