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PF-07612577 (pf-07612577)
PF-07612577 (generic name: pf-07612577) is a drug developed by Pfizer Inc.. It is currently in Phase 1 development.
PF-07612577 is a small molecule modality, specifically a prodrug of Avibactam. It is being studied in a clinical trial (NCT06593054) to evaluate its pharmacokinetics in healthy adults, with the study medicine administered as a tablet formulation of Ceftibuten and Avibactam prodrug (CTB-AVP).
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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). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | pf-07612577 |
|---|---|
| Sponsor | Pfizer Inc. |
| Phase | Phase 1 |
Approved indications
Common side effects
- Abdominal pain lower
- Dizziness
- Presyncope
- Palpitations
- Ear pain
- Abdominal discomfort
- Abdominal distension
- Abdominal pain
- Abdominal pain upper
- Diarrhoea
- Diarrhoea haemorrhagic
- Dry mouth
Key clinical trials
- To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy Adults (PHASE1)
- A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People. (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:
- PF-07612577 CI brief — competitive landscape report
- PF-07612577 updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about PF-07612577
What is PF-07612577?
Who makes PF-07612577?
What is the generic name of PF-07612577?
What development phase is PF-07612577 in?
What are the side effects of PF-07612577?
Related
- Manufacturer: Pfizer Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing