Drugs / Nimacimab
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03261739 | Aug 2017 → Aug 2018 | fatty liver disease | Bird Rock Bio, Inc. | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT06577090 | Aug 2024 → Nov 2026 expected | obesity disorder | Skye Bioscience, Inc. | Active not recruiting | Missed primary |
| Phase 2 | NCT03900325 | Aug 2019 → Jan 2020 | gastroparesis | Bird Rock Bio, Inc. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-05-20 | Skye Bioscience, Inc. | Results Skye Announces Cohort Review Committee Approved Opening of Cohort 2 Based on Favorable Safety Data from First Four Participants Treated in Cohort 1 skyebioscience.com ↗
No Serious Adverse Events or Adverse Events of Special Interest Were Reported Following 4 Weeks of Treatment |
| 2026-03-10 | Skye Bioscience, Inc. | Results Skye Bioscience Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update skyebioscience.com ↗ |
| 2026-02-02 | Skye Bioscience, Inc. | Results Skye Reports Positive CBeyond Phase 2a Extension Interim Study Results for Nimacimab in Combination With Semaglutide skyebioscience.com ↗ |
| 2026-01-29 | Skye Bioscience, Inc. | Results Skye Bioscience Highlights Attributes of its Peripherally-restricted CB1 Inhibitor Antibody at Keystone Obesity Conference skyebioscience.com ↗
Nimacimab showed significant additive weight loss effects when combined with suboptimal or clinically active dose levels of tirzepatide (39% and 46% weight loss respectively). |
| 2025-11-05 | Skye Bioscience, Inc. | Results Skye Bioscience Late-Breaking Oral Abstract at ObesityWeek 2025 to Highlight Improvement in Rebound Weight Gain skyebioscience.com ↗
New data from an analysis of participants 12 weeks post-treatment demonstrated that nimacimab 200 mg (subcutaneous, weekly) plus semaglutide blunted rebound weight gain compared to semaglutide alone (18.1% versus 49.8% weight regain over 12 weeks). |
| 2025-10-06 | Skye Bioscience, Inc. | Results Skye Bioscience Reports Topline CBeyond™ Phase 2a Data from Nimacimab Monotherapy and Combination Clinical Trial skyebioscience.com ↗
In the combination cohort, nimacimab 200 mg (subcutaneous, weekly) plus semaglutide demonstrated a clinically meaningful magnitude of weight loss compared to semaglutide alone (-13.2% vs -10.25%, p=0.0372, mITT), with no plateau being observed through Week 26. |
| 2025-09-19 | Skye Bioscience, Inc. | Results Skye Presents Phase 1b Data for its Peripheral CB1-inhibiting Antibody, Nimacimab, at European Association for the Study of Diabetes (EASD) Annual Meeting skyebioscience.com ↗
The study demonstrated that nimacimab was safe, well-tolerated, and exhibited predictable pharmacokinetics and low immunogenicity across multiple ascending dose cohorts. |
| 2025-09-04 | Skye Bioscience, Inc. | Results Skye’s CB1 Inhibitor, Nimacimab, Demonstrates Superior Weight Loss and Differentiated Mechanisms from Monlunabant, and Continues to Show Enhanced Combination with Tirzepatide with Durable Post-Treatment Weight Maintenance in DIO Model skyebioscience.com ↗
The second study re-evaluated the combination of nimacimab, this time with both optimal and sub-optimal doses of tirzepatide, and continued to show enhanced weight loss effects compared to tirzepatide alone, while also limiting rebound after treatment with tirzepatide is stopped. |
| 2025-05-13 | Skye Bioscience, Inc. | Results Skye Bioscience Clinical Model Demonstrating Necessity of Peripheral CB1 Inhibition for Weight Loss Presented at European Congress on Obesity skyebioscience.com ↗
Anti-CB1 inhibiting antibody, nimacimab, showed greatest peripheral restriction compared with monlunabant and rimonabant, small molecule-based CB1 inhibitors, which both exhibited increasing dose-dependent brain penetration |
| 2025-05-08 | Skye Bioscience, Inc. | Results Skye Bioscience Reports First Quarter 2025 Results and Highlights Nimacimab Differentiation in Obesity skyebioscience.com ↗
In vitro data reported from new preclinical study highlights superior potency of peripherally restricted CB1 inhibitor, nimacimab, versus monlunabant when tested under pathological levels of CB1 agonists |
| 2025-04-15 | Skye Bioscience, Inc. | Results Skye Bioscience Demonstrates Over 30% Weight Loss with Nimacimab and Tirzepatide Combination in Preclinical Model skyebioscience.com ↗
Nimacimab alone demonstrated 23.5% weight loss, comparable to monlunabant and tirzepatide alone. |
| 2024-11-04 | Skye Bioscience, Inc. | Results Skye Bioscience Demonstrates Prominent Role of Peripheral CB1 Inhibition and Achieves Significant Weight Loss with Novel CB1-inhibiting Antibody, Nimacimab, in Preclinical Model skyebioscience.com ↗
Skye’s CB1-inhibiting antibody, nimacimab, achieved significant dose-dependent weight loss of up to 16% compared to vehicle, highlighting a novel peripherally-driven mechanism for inducing weight loss and other metabolic benefits. |
| 2024-07-24 | Skye Bioscience, Inc. | Regulatory Skye Bioscience Hosts Virtual KOL Event, “Metabolic Rewiring with CB1 Inhibition,” and Details Phase 2 Nimacimab Clinical Trial Design Including Obstructive Sleep Apnea Exploratory Endpoints skyebioscience.com ↗
Skye has amended its open Investigational New Drug (IND) application for Nimacimab with an updated clinical trial protocol for its Phase 2 study. |
| 2024-01-09 | Skye Bioscience, Inc. | Regulatory Skye Bioscience Receives IND Clearance for Phase 2 Clinical Trial of Nimacimab in Obesity and Chronic Kidney Disease skyebioscience.com ↗
Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing drugs targeting the endocannabinoid system, has received clearance of its Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") to initiate a Phase 2 clinical trial of nimacimab in patients with obesity and chronic kidney disease. |
| 2023-12-11 | Skye Bioscience, Inc. | Regulatory Skye Announces Clinical Development Plan in Obesity for Differentiated Peripheral CB1 Inhibitor, Nimacimab skyebioscience.com ↗
The Company has filed an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for the initiation of a Phase 2 clinical study of nimacimab in patients with obesity and chronic kidney disease. |
All press releases naming this drug 23 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nimacimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06577090 ↗ |
| Known as | JNJ-2463 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298095 ↗ |
| Known as | RYI-018 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03261739 ↗ |
| Action | Inhibit | “Cannabinoid CB1 receptor negative allosteric modulator” CHEMBL4298095 ↗ |
| Modality | Monoclonal antibody | “Anti-CB1 monoclonal antibody” NCT03261739 ↗ |
| Route | Intravenous | “repeat IV doses of RYI-018” NCT03261739 ↗ |
| Target | CNR1 | “Cannabinoid CB1 receptor negative allosteric modulator” CHEMBL4298095 ↗ |