This section highlights FDA-related milestones and regulatory updates for drugs developed by Revelation Biosciences (REVB).
Over the past two years, Revelation Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Gemini, interleukin-10, PRIME, and RVL-HV02. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Gemini - FDA Regulatory Timeline and Events
Gemini is a drug developed by Revelation Biosciences for the following indication: In patients with CKD.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Gemini
- Announced Date:
- December 2, 2024
- Indication:
- In patients with CKD.
Announcement
Revelation Biosciences, Inc announced that the United States Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for Gemini.
AI Summary
Revelation Biosciences, Inc. announced that the FDA has accepted its investigational new drug (IND) application for Gemini. This decision allows the company to start its US-based Phase 1b clinical study early in 2025. The trial will include about 40 patients with chronic kidney disease (CKD) organized into up to five cohorts. The main goal of the study is to evaluate the safety and tolerability of a single dose of Gemini, while secondary objectives focus on understanding how the drug is processed in the body and its impact on the immune response by tracking specific biomarkers.
Positive results from this trial could lead to a Phase 2 study assessing whether Gemini can lower the incidence, duration, and severity of acute kidney injury in patients undergoing cardiac surgeries. This milestone demonstrates Revelation’s commitment to harnessing trained immunity to improve patient outcomes.
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interleukin-10 - FDA Regulatory Timeline and Events
interleukin-10 is a drug developed by Revelation Biosciences for the following indication: Anti-inflammatory cytokine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- interleukin-10
- Announced Date:
- September 24, 2024
- Indication:
- Anti-inflammatory cytokine
Announcement
Revelation Biosciences, Inc announced statistically significant, dose dependent increases of interleukin-10 (IL-10) in response to Gemini treatment, using a high sensitivity analysis. This additional positive data follows the previously reported positive topline data from the Phase 1 clinical study of Gemini released on June 24, 2024.
AI Summary
Revelation Biosciences announced that its Gemini treatment produced statistically significant, dose-dependent increases in interleukin-10 (IL-10) in healthy volunteers. Using a high sensitivity analysis, researchers measured IL-10 levels two hours after administering Gemini at low, mid, and high doses, which resulted in 27-fold, 162-fold, and 309-fold increases respectively compared to placebo. IL-10 is a key anti-inflammatory protein that helps to reduce inflammation by downregulating pro-inflammatory cytokines. The observed increases confirm that Gemini can effectively modulate the innate immune response through TLR4 binding, promoting the resolution of inflammation and initiating the healing process. This new data builds on previous positive results from the Phase 1 study and highlights Gemini’s potential as a therapeutic preconditioning treatment to manage inflammation and improve patient outcomes.
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PRIME - FDA Regulatory Timeline and Events
PRIME is a drug developed by Revelation Biosciences for the following indication: In CKD Patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PRIME
- Announced Date:
- February 26, 2025
- Indication:
- In CKD Patients
Announcement
Revelation Biosciences, Inc. announced dosing of the first patient in the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of intravenous single ascending doses of Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD).
AI Summary
Revelation Biosciences, Inc. has begun dosing the first patient in its PRIME Phase 1b clinical study testing Gemini, an intravenous drug designed to rebalance the immune response. This study will use single ascending doses of Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). It is a US-based, multi-site, placebo-controlled trial expected to enroll up to 40 patients divided into five cohorts. The aim of the study is to assess Gemini’s safety, tolerability, and its effects on key biomarkers related to inflammation. Top-line data from the trial, which will provide insights into the drug’s effectiveness in reducing the inflammatory response, are anticipated by mid-year. This initial step marks an important milestone as Revelation Biosciences moves forward in exploring Gemini’s potential to benefit patients with CKD.
Read Announcement- Drug:
- PRIME
- Announced Date:
- January 21, 2025
- Indication:
- In CKD Patients
Announcement
Revelation Biosciences, Inc announced that it has started its PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of escalating doses of intravenously administered Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD).
AI Summary
Revelation Biosciences, Inc. has initiated its PRIME Phase 1b clinical study focused on patients with Stage 3 and 4 Chronic Kidney Disease (CKD). The study uses escalating doses of an intravenously administered formulation called Gemini. Designed as a multi-site, placebo-controlled trial, the study will enroll up to forty patients across five dose-escalation cohorts. The primary goal is to evaluate the safety, tolerability, and pharmacodynamic biomarkers that indicate Gemini's effectiveness. Dosing for the study is set to begin in mid-February, with topline data anticipated by mid-year. Revelation Biosciences plans to use these insights to support further clinical development in both its GEM-CKD and GEM-AKI programs, aiming to improve treatment methods for CKD and prevent acute kidney injury (AKI). The company is enthusiastic about the study and intends to share important information on CKD biomarkers and treatment implications in the coming months.
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RVL-HV02 - FDA Regulatory Timeline and Events
RVL-HV02 is a drug developed by Revelation Biosciences for the following indication: to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RVL-HV02
- Announced Date:
- June 13, 2024
- Indication:
- to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program)
Announcement
Revelation Biosciences, Inc announced that it has completed enrollment and dosing of its first in human Phase 1 clinical study (RVL-HV02).
AI Summary
Revelation Biosciences, Inc. has finished enrolling and dosing 40 healthy adults, aged 18 to 55, in its first in human Phase 1 clinical study, RVL-HV02, conducted in Australia. The study used escalating doses of Gemini, the company’s proprietary formulation, administered intravenously to evaluate its safety and tolerability.
Top-line data, which will include primary safety end points and exploratory biomarkers of immune activity, are expected soon. If these results are positive, they could support further development of Gemini for multiple indications, opening the door to new treatment options that harness the power of trained immunity for various critical health needs.
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