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Orapenem (TEBIPENEM PIVOXIL)
Orapenem (generic name: TEBIPENEM PIVOXIL) is a tebipenem pivoxil drug. It is currently in Phase 3 development.
Orapenem works by inhibiting the bacterial enzyme transpeptidase, which is essential for bacterial cell wall synthesis.
Orapenem is a small molecule that inhibits bacterial penicillin-binding protein. It is being studied as an alternative to Ceftriaxone for treating clinically non-responding children with Shigellosis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | TEBIPENEM PIVOXIL |
|---|---|
| Drug class | tebipenem pivoxil |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 3 |
Mechanism of action
Think of the bacterial cell wall like a brick wall. Orapenem blocks the enzyme that helps put the bricks together, causing the wall to weaken and eventually collapse. This ultimately leads to the death of the bacterial cell.
Approved indications
Common side effects
Key clinical trials
- A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) (PHASE3)
- Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care (PHASE4)
- Tebipenem Trial in Children With Shigellosis (PHASE2)
- A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants (PHASE1)
- A Study to Compare Two Bioanalytical Assays for Tebipenem (PHASE1)
- Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis (PHASE1)
- Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) (PHASE3)
- Effect of Tebipenem on Normal Human Intestinal Microbiota (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:
- Orapenem CI brief — competitive landscape report
- Orapenem updates RSS · CI watch RSS
Frequently asked questions about Orapenem
What is Orapenem?
How does Orapenem work?
What is the generic name of Orapenem?
What drug class is Orapenem in?
What development phase is Orapenem in?
Related
- Drug class: All tebipenem pivoxil drugs
- Therapeutic area: All drugs in Metabolic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing