SEROMYCIN (cycloserine) · SANALUZ
Cycloserine is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, cycloserine should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1964-06-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE
SEROMYCIN Approval History
What SEROMYCIN Treats
2 indicationsSEROMYCIN is approved for 2 conditions since its original approval in 1964. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tuberculosis
- Urinary Tract Infection
SEROMYCIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SEROMYCIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06081361 INSPIRE-CODA | BJCH-202301 | Ph 3 | active not recruiting | Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort |
| NCT05081986 | REB21-0863 | Ph 2 | completed | Repeated iTBS Cycloserine Motor Plasticity |
| NCT03511599 | REB18-0604 | Ph 1 | completed | Cycloserine rTMS Plasticity Augmentation in Depression |
| NCT02735694 | B2013:044 MA-7954, 9427-U0304-36C | Ph 1 | terminated | Cycloserine in the Treatment of Sleep Apnea |
| NCT03432689 | REB17-2314 | Ph 1 | completed | Cycloserine rTMS Plasticity Augmentation |
| NCT02933684 | ULTR000454 | Ph 2 | withdrawn | D-Cycloserine and Virtual Reality Exposure Therapy |
| NCT01062932 | H-23305 R21DA023588, DPMC | Ph 1 | completed | Investigation of Cycloserine as a Smoking Cessation Treatment |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
SEROMYCIN FDA Label Details
Indications & Usage
Cycloserine is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, cycloserine should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent. Cycloserine may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram-positive and gram- negati...
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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