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RBT-1
RBT-1 is a ACE inhibitor Small molecule drug developed by Renibus Therapeutics, Inc.. It is currently in Phase 3 development for Hypertension.
RBT-1 is a small molecule that targets the renin-angiotensin system to treat hypertension.
RBT-1 is a treatment being studied in a Phase 1b clinical trial for conditions such as Acute Kidney Injury, Post-Operative Complications in Cardiac Surgery, and Chronic Kidney Disease. The trial is being conducted by Renibus Therapeutics, Inc. to assess the safety and efficacy of RBT-1 in healthy volunteers and subjects with Chronic Kidney Disease Stage 3b-4.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | RBT-1 |
|---|---|
| Sponsor | Renibus Therapeutics, Inc. |
| Drug class | ACE inhibitor |
| Target | ACE |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
RBT-1 works by inhibiting the angiotensin-converting enzyme (ACE), which is a key component of the renin-angiotensin system. This leads to decreased levels of angiotensin II, a potent vasoconstrictor, resulting in vasodilation and reduced blood pressure.
Approved indications
- Hypertension
Common side effects
- Cough
- Dizziness
- Headache
Key clinical trials
- A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease (PHASE1)
- An Evaluation of Patient Reported Outcomes and Clinical Outcomes
- Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery (PHASE3)
- Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery (PHASE2)
- RBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD (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:
- RBT-1 CI brief — competitive landscape report
- RBT-1 updates RSS · CI watch RSS
- Renibus Therapeutics, Inc. portfolio CI
Frequently asked questions about RBT-1
What is RBT-1?
How does RBT-1 work?
What is RBT-1 used for?
Who makes RBT-1?
What drug class is RBT-1 in?
What development phase is RBT-1 in?
What are the side effects of RBT-1?
What does RBT-1 target?
Related
- Drug class: All ACE inhibitor drugs
- Target: All drugs targeting ACE
- Manufacturer: Renibus Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertension
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing