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Septra
Septra is a Small molecule drug developed by 59th Medical Wing. It is currently in Phase 1 development. Also known as: Bactrim, Sulfamethoxazole/trimethoprim.
Septra is a fixed-dose combination antibiotic medication used to treat various bacterial infections, including urinary tract infections, methicillin-resistant Staphylococcus aureus (MRSA) skin infections, and others. It consists of one part trimethoprim to five parts sulfamethoxazole and works by inhibiting bacterial dihydrofolate reductase.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Septra |
|---|---|
| Also known as | Bactrim, Sulfamethoxazole/trimethoprim |
| Sponsor | 59th Medical Wing |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Prevent TB: Choice Architecture for TPT Delivery (NA)
- A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) (PHASE2)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM (PHASE3)
- Effects of Treatments on Atopic Dermatitis (PHASE2)
- Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial (NA)
- Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients (PHASE4)
- Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Septra CI brief — competitive landscape report
- Septra updates RSS · CI watch RSS
- 59th Medical Wing portfolio CI
Frequently asked questions about Septra
What is Septra?
Who makes Septra?
Is Septra also known as anything else?
What development phase is Septra in?
Related
- Manufacturer: 59th Medical Wing — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Bactrim, Sulfamethoxazole/trimethoprim
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing