Last reviewed · How we verify
PLA (Panto+Levoflox+Azithro)
PLA (Panto+Levoflox+Azithro) is a Combination therapy (proton pump inhibitor + fluoroquinolone + macrolide) Small molecule drug developed by Asofarma de México S.A de C.V.. It is currently in Phase 3 development for Helicobacter pylori infection eradication, Acid-related gastrointestinal disorders with concurrent infection. Also known as: Zoltum®, Truxa® (MTV SA, Argentina), Levofloxacino, AsoMex.
PLA is a triple-agent combination that reduces gastric acid (pantoprazole), inhibits bacterial DNA gyrase (levofloxacin), and suppresses protein synthesis (azithromycin) to treat infections and acid-related disorders.
The PLA (Panto+Levoflox+Azithro) combination is a small molecule treatment modality for Helicobacter Pylori Gastritis. It is being studied as an alternative to CLA (Clarithro+Lanso+Amoxi) in clinical trials for Helicobacter Pylori eradication.
-
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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| 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 | PLA (Panto+Levoflox+Azithro) |
|---|---|
| Also known as | Zoltum®, Truxa® (MTV SA, Argentina), Levofloxacino, AsoMex |
| Sponsor | Asofarma de México S.A de C.V. |
| Drug class | Combination therapy (proton pump inhibitor + fluoroquinolone + macrolide) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Pantoprazole is a proton pump inhibitor that suppresses gastric acid secretion. Levofloxacin is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication. Azithromycin is a macrolide antibiotic that binds to the bacterial 50S ribosomal subunit, inhibiting protein synthesis. Together, these agents provide acid suppression and broad-spectrum antimicrobial coverage.
Approved indications
- Helicobacter pylori infection eradication
- Acid-related gastrointestinal disorders with concurrent infection
Common side effects
- Diarrhea
- Nausea
- Abdominal discomfort
- Headache
- QT prolongation (azithromycin)
- Tendinopathy (fluoroquinolone)
Key clinical trials
- Triple Therapy Versus Levofloxacin-based Therapy for Helicobacter Pylori Eradication in Mexico. (PHASE3)
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:
- PLA (Panto+Levoflox+Azithro) CI brief — competitive landscape report
- PLA (Panto+Levoflox+Azithro) updates RSS · CI watch RSS
- Asofarma de México S.A de C.V. portfolio CI
Frequently asked questions about PLA (Panto+Levoflox+Azithro)
What is PLA (Panto+Levoflox+Azithro)?
How does PLA (Panto+Levoflox+Azithro) work?
What is PLA (Panto+Levoflox+Azithro) used for?
Who makes PLA (Panto+Levoflox+Azithro)?
Is PLA (Panto+Levoflox+Azithro) also known as anything else?
What drug class is PLA (Panto+Levoflox+Azithro) in?
What development phase is PLA (Panto+Levoflox+Azithro) in?
What are the side effects of PLA (Panto+Levoflox+Azithro)?
Related
- Drug class: All Combination therapy (proton pump inhibitor + fluoroquinolone + macrolide) drugs
- Manufacturer: Asofarma de México S.A de C.V. — full pipeline
- Therapeutic area: All drugs in Gastroenterology / Infectious Disease
- Indication: Drugs for Helicobacter pylori infection eradication
- Indication: Drugs for Acid-related gastrointestinal disorders with concurrent infection
- Also known as: Zoltum®, Truxa® (MTV SA, Argentina), Levofloxacino, AsoMex
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing