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Low dose Kaletra tablets
Low dose Kaletra tablets is a Small molecule drug developed by Phoenix Children's Hospital. It is currently in Phase 1 development. Also known as: lopinavir/ritonavir 100mg/25mg.
Low-dose Kaletra tablets contain a combination of darunavir and ritonavir, which are used to treat Human Immunodeficiency Virus (HIV) and COVID-19. The exact mechanism of action of Kaletra is unknown, but it is used as part of postexposure prophylaxis (PEP) for HIV.
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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).
| 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 | Low dose Kaletra tablets |
|---|---|
| Also known as | lopinavir/ritonavir 100mg/25mg |
| Sponsor | Phoenix Children's Hospital |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Diarrhoea
- Nausea
- Fatigue
- Headache
- Abdominal Pain Upper
- Vomiting
- Rash
- Dizziness
- Asthenia
- Flatulence
- Decreased Appetite
- Dysgeusia
Key clinical trials
- Randomised Evaluation of COVID-19 Therapy (PHASE3)
- COVID-19 Study at the Russian Clinical and Research Center of Gerontology of the Pirogov RNRMU
- Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) (PHASE3)
- Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children (PHASE2)
- Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL) (PHASE3)
- Comparison of Liquid Kaletra and Low Dose Kaletra Tablets (NA)
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:
- Low dose Kaletra tablets CI brief — competitive landscape report
- Low dose Kaletra tablets updates RSS · CI watch RSS
- Phoenix Children's Hospital portfolio CI
Frequently asked questions about Low dose Kaletra tablets
What is Low dose Kaletra tablets?
Who makes Low dose Kaletra tablets?
Is Low dose Kaletra tablets also known as anything else?
What development phase is Low dose Kaletra tablets in?
What are the side effects of Low dose Kaletra tablets?
Related
- Manufacturer: Phoenix Children's Hospital — full pipeline
- Also known as: lopinavir/ritonavir 100mg/25mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing