Data updated: Jun 28, 2026
FURALAN (nitrofurantoin) · CHARTWELL MOLECULAR
Trial Activity: Mature 4 active trials
Infectious Disease
Approved 1970-09-30
FURALAN is FDA-approved to treat 1 condition (same as NITROFURANTOIN).
Source: FDA Label
Development Insights
GlaxoSmithKline conducting 4 trials (22%)
18 indications explored (Broad Platform)
→ urinary tract infections (9 trials)
→ urinary tract infection (2 trials)
→ antibiotic prophylaxis (2 trials)
1
Indication
--
Phase 3 Trials
55
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1970-09-30
- Routes
- ORAL
- Dosage Forms
- TABLET
FURALAN Approval History
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Original
New Indication
New Form
Label Update
4 FDA actions from 1970 to 2014
Jun 2014 SUPPL
Label · Labeling
Sep 1970 ORIGINAL
Update
What FURALAN Treats
1 indicationsFURALAN is approved for 1 conditions since its original approval in 1970. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as NITROFURANTOIN (same active ingredient).
Source: FDA Label
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Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06332781 | 2126175 // CTR grant U54GM1156 | Ph 4 | completed | Intravesical Gentamicin to Prevent Recurrent UTI |
| NCT05138822 results posted | 212943 | Ph 1 | completed | Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections |
| NCT05274672 | 022-046 | Ph 4 | withdrawn | Role of Prophylactic Postoperative Antibiotics in HoLEP |
| NCT07186465 microbiome | MURA2024/339 Ref.2024/671 | Ph 4 | recruiting | Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis |
| NCT04959331 SCOUT | IJG-SCOUT-2021 | Ph 4 | completed | Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women. |
| NCT04502095 | I 573720 NCI-2020-04928, I 573720 | Ph 4 | completed | Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy |
| NCT05630833 EAGLE-J results posted | 214144 | Ph 3 | completed | A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis) |
| NCT06709196 REINFORCE | 2024-514312-27-00 2024-514312-27-00 | Ph 4 | recruiting | Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis |
| NCT05652374 GT RACING | 111802 NL76892.091.21 | Ph 4 | recruiting | Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study |
| NCT05519072 | 1889711-1 | Ph 4 | recruiting | Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA |
| NCT04187144 results posted | 212390 2020-000553-27 | Ph 3 | completed | Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI) |
| NCT04020341 results posted | 204989 2018-001801-98 | Ph 3 | completed | A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI) |
| NCT05600023 | Intracanal medication | Ph 4 | completed | The Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste |
| NCT05254808 EXFOCY | NL75841.041.20 | Ph 3 | terminated | EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care |
| NCT03299387 INSTANT | 11-002887 | Ph 4 | withdrawn | INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI |
| NCT02727322 results posted | PRO15110557 | Ph 4 | completed | Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery |
| NCT01450800 STOPP UTI results posted | Pro00025269 3913577 | Ph 4 | completed | Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI) |
| NCT00734968 results posted | 1108717 | Ph 4 | completed | Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
FURALAN FDA Label Details
Indications & Usage
FURALAN is FDA-approved to treat 1 condition — same approved indications as NITROFURANTOIN.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment