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UK-453, 061
UK-453, 061 is a Small molecule drug developed by Pfizer. It is currently in Phase 2 development.
UK-453,061 is a drug that was studied in a clinical trial to investigate its interaction with rifabutin in healthy volunteers. The study also involved lersivirine, and was conducted to estimate the interaction between multiple dose rifabutin and UK-453,061 in healthy subjects.
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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). -
Big-pharma sponsor
+3.0pp
Pfizer 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 | 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 | UK-453, 061 |
|---|---|
| Sponsor | Pfizer |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1 (PHASE2)
- Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects (PHASE1)
- Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects (PHASE1)
- Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061) (PHASE1)
- Bioavailability Of Lersivirine Single 750 Mg Tablet Versus 3 X 250 Mg Tablets (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:
- UK-453, 061 CI brief — competitive landscape report
- UK-453, 061 updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about UK-453, 061
What is UK-453, 061?
Who makes UK-453, 061?
What development phase is UK-453, 061 in?
Related
- Manufacturer: Pfizer — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing