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
PRIME, Gemini, and interleukin-10. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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:
- March 30, 2026
- Indication:
- In CKD Patients
Announcement
Revelation Biosciences, presented additional positive data analysis from the PRIME Study at the International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2026) in San Diego (March 29 - April 1, 2026).
AI Summary
Revelation Biosciences presented additional positive data analysis from the PRIME Study at the International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2026) in San Diego (March 29–April 1, 2026). The PRIME results show that a majority of chronic kidney disease (CKD) patients had cellular inflammation and immunoparalysis before dosing, and that a single dose of Gemini durably normalized cellular inflammation at the cellular level and restored immunocompetence. The company links disease progression to excess cytokine production from activated innate immune cells.
James Rolke, Revelation’s CEO, said the company was pleased to share these clinical findings with key opinion leaders and clinicians treating acute kidney injury (AKI). He framed the conference engagement as an important step toward initiating a planned pivotal AKI study later this year.
Revelation is a clinical‑stage company developing Gemini, a proprietary formulation being evaluated in multiple programs for AKI, CKD and other acute or chronic conditions driven by dysregulated inflammation. More information is available at www.RevBiosciences.com.
Read Announcement- Drug:
- PRIME
- Announced Date:
- November 20, 2025
- Indication:
- In CKD Patients
Announcement
Revelation Biosciences, Inc announced successful submission and acceptance of the end-of-phase 1 meeting package to FDA and that the company is on track to hold the meeting later this year.
AI Summary
Revelation Biosciences announced it successfully submitted an end-of-phase 1 meeting package and that the FDA has accepted it, with the company on track to hold the meeting later this year. The primary aim of the meeting is to obtain FDA feedback on the clinical development and regulatory approval pathway for Gemini as a treatment for acute kidney injury (AKI).
CEO James Rolke said the team worked hard on the submission and looks forward to the scheduled meeting. Revelation’s near-term plans include completing activities needed to start and run a later-stage clinical study in 2026 to assess Gemini’s ability to treat AKI. The company also plans to publish additional PRIME study results and to explore expanding Gemini’s uses through further preclinical and clinical testing. These steps are intended to clarify the development path and next regulatory milestones for the drug candidate.
Read Announcement- Drug:
- PRIME
- Announced Date:
- September 10, 2025
- Indication:
- In CKD Patients
Announcement
Revelation Biosciences, Inc to review groundbreaking activity data from its Phase 1b PRIME clinical study in stage 3 and 4 chronic kidney disease (CKD) patients.
AI Summary
Revelation Biosciences will host a webcast on September 10, 2025, at 8:30 a.m. ET to review groundbreaking activity data from its Phase 1b PRIME clinical study in stage 3 and 4 chronic kidney disease (CKD) patients. The presentation will cover key findings on Gemini, the company’s proprietary formulation, including safety, tolerability and effects on kidney function and inflammation markers. Early results suggest Gemini may slow disease progression and improve clinical outcomes for advanced CKD patients.
Investors and healthcare professionals can access the live webcast online or via phone by dialing 888-506-0062 (US toll free) or +1 973-528-0011 (international) with participant code 289672. Presentation slides and replay details will be available on Revelation’s website. This review marks a critical milestone in developing new treatments that target inflammation in chronic kidney disease.
Read Announcement- Drug:
- PRIME
- Announced Date:
- July 16, 2025
- Indication:
- In CKD Patients
Announcement
Revelation Biosciences announced dosing has been completed for the 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 announced that dosing has been completed for its PRIME Phase 1b clinical study. This study tests escalating doses of Gemini, an intravenously administered formulation, in patients suffering from Stage 3 and 4 Chronic Kidney Disease (CKD). The study enrolled five cohorts across three clinics in the United States, and the dosing phase was completed ahead of schedule.
Several data sets are expected to be available in the third quarter of 2025, including safety parameters, hematologic changes, and the inflammatory response measured in blood cells. The company is set to release these study findings soon and looks forward to discussing clinical development and approval pathways with the FDA later this year. This advancement marks an important step in evaluating Gemini’s potential to mitigate the inflammation processes associated with CKD.
Read Announcement- 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.
Read Announcement
Gemini FDA Regulatory 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.
Read Announcement
Interleukin-10 FDA Regulatory 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.
Read Announcement
