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PNU-100480
PNU-100480 is a Small molecule drug developed by Sequella, Inc.. It is currently in Phase 2 development. Also known as: Period 2, Period 3, Period 1, Period 4 (Fed).
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | PNU-100480 |
|---|---|
| Also known as | Period 2, Period 3, Period 1, Period 4 (Fed) |
| Sponsor | Sequella, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (PHASE2)
- A Pan-TB Regimen Targeting Host and Microbe (PHASE2, PHASE3)
- Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis (PHASE2)
- The Individualized M(X) Drug-resistant TB Treatment Strategy Study (PHASE4)
- PanACEA Sutezolid Dose-finding and Combination Evaluation (PHASE2)
- Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid (PHASE1)
- PNU-100480 In Newly Diagnosed, Drug Sensitive Patients With Pulmonary TB; Early Bactericidal Activity; Whole Blood Assay (PHASE2)
- Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers (PHASE1)
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:
- PNU-100480 CI brief — competitive landscape report
- PNU-100480 updates RSS · CI watch RSS
- Sequella, Inc. portfolio CI
Frequently asked questions about PNU-100480
What is PNU-100480?
Who makes PNU-100480?
Is PNU-100480 also known as anything else?
What development phase is PNU-100480 in?
Related
- Manufacturer: Sequella, Inc. — full pipeline
- Also known as: Period 2, Period 3, Period 1, Period 4 (Fed)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing