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Regiocit
Regiocit is a Small molecule drug developed by Vantive Health LLC. It is currently in Phase 2 development. Also known as: Sodium citrate replacement solution.
Regiocit is a treatment being studied in clinical trials for conditions such as Renal Insufficiency, Renal Replacement Therapy, Critical Care, Critically Ill, and Acute Kidney Injury. It is being investigated as part of a registry study, "Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy (PrioR)", which also includes other interventions like Biphozyl and Prismasol 2.
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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).
| 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 | Regiocit |
|---|---|
| Also known as | Sodium citrate replacement solution |
| Sponsor | Vantive Health LLC |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Citrate Anticoagulation in Renal Replacement Therapy: Impact of a High Post-filter Calcium Target on Efficacy (PHASE3)
- Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy
- Comparison of Biphozyl® and Phoxilium® as a Replacement Fluid During CVVH for AKI in Adults and Their Effects on pH-, Bicarbonate-levels and Respiratory Situation (PHASE2)
- Efficacy and Safety of a Citrate-based Anticoagulation With Calcium-free Phosphate-containing Fluid in Renal Replacement Therapy (PHASE4)
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:
- Regiocit CI brief — competitive landscape report
- Regiocit updates RSS · CI watch RSS
- Vantive Health LLC portfolio CI
Frequently asked questions about Regiocit
What is Regiocit?
Who makes Regiocit?
Is Regiocit also known as anything else?
What development phase is Regiocit in?
Related
- Manufacturer: Vantive Health LLC — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Sodium citrate replacement solution
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing