Drugs / SBI-100
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | glaucoma | 2022-11-17 | “has submitted an Investigational New Drug application ("IND") to the U.S. Food and Drug Administration for SBI-100 Ophthalmic Emulsion” skyebioscience.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06144918 | Nov 2023 → Feb 2024 | ocular hypertension, open-angle glaucoma | Skye Bioscience, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2024-06-10 | Skye Bioscience, Inc. | Results Skye Concentrates Strategy and Clinical Development Focus on Nimacimab Metabolic Program skyebioscience.com ↗
Skye Bioscience, Inc. (Nasdaq: SKYE) ("Skye" or the "Company”), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel classes of therapeutic drugs that modulate the endocannabinoid system, announced that its Phase 2a clinical trial of SBI-100 Ophthalmic Emulsion ("OE") in patients with primary open-angle glaucoma ("POAG") or ocular hypertension ("OHT") did not meet its primary endpoint for lowering intraocular pressure (“IOP”). |
| 2023-10-25 | Skye Bioscience, Inc. | Results Skye Bioscience Announces Positive Phase 1 Trial Results for SBI-100 Ophthalmic Emulsion, Its First-in-Class CB1 Agonist Being Developed for the Treatment of Glaucoma skyebioscience.com ↗ |
| 2023-07-13 | Skye Bioscience, Inc. | Results Skye Bioscience Receives Positive Safety Review for Final Cohort of Fully-Enrolled Phase 1 Study of SBI-100 Ophthalmic Emulsion skyebioscience.com ↗
Data reported for the final cohort is consistent with the previously reported five cohorts, with no serious adverse events. |
| 2023-06-02 | Skye Bioscience, Inc. | Results Skye Bioscience Receives Positive Safety Review of Fifth Cohort of Phase 1 Study of SBI-100 Ophthalmic Emulsion skyebioscience.com ↗
The related adverse events reported across all cohorts are typically associated with topical eye treatments. |
| 2023-05-15 | Skye Bioscience, Inc. | Results Skye Bioscience Receives Positive Safety Review in First Multiple-Administration Cohort of Phase 1 Study of SBI-100 Ophthalmic Emulsion skyebioscience.com ↗
The data from the fourth cohort was consistent with previous cohorts; there were no serious adverse events and similar mild to moderate drug-related adverse events. |
| 2023-04-04 | Skye Bioscience, Inc. | Results Skye Bioscience Receives Positive Safety Review of Third Cohort in Phase 1 Study of SBI-100 Ophthalmic Emulsion skyebioscience.com ↗
The SRC determined that in Cohort 3, the highest dose cohort (2.0% concentration), the data was consistent with Cohorts 1 and 2 (0.5% and 1.0% concentration, respectively), with no serious adverse events, and mild and moderate drug related adverse events. |
| 2023-03-15 | Skye Bioscience, Inc. | Regulatory Skye Bioscience Receives Human Research Ethics Committee Approval to Start Multiple Ascending Dose Arm of Phase 1 Study of SBI-100 Ophthalmic Emulsion skyebioscience.com ↗ |
| 2023-02-23 | Skye Bioscience, Inc. | Results Skye Bioscience Receives Positive Safety Review of SBI-100 Ophthalmic Emulsion After Second Cohort of Phase 1 Study skyebioscience.com ↗
The SRC determined that, as in Cohort 1, SBI-100 OE was well-tolerated, with no drug-related serious adverse events and only mild adverse events related to SBI-100 OE were reported. |
| 2023-01-31 | Skye Bioscience, Inc. | Results Skye Bioscience Achieves Positive Safety Review of SBI-100 Ophthalmic Emulsion After Phase 1 First Cohort skyebioscience.com ↗
They determined that SBI-100 OE was well-tolerated, with no drug-related serious adverse events and only mild adverse events related to SBI-100 OE were reported. |
| 2022-12-20 | Skye Bioscience, Inc. | Regulatory Skye Bioscience Receives FDA Authorization of Investigational New Drug Application for SBI-100 OE skyebioscience.com ↗
Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, today announced that the U.S. Food and Drug Administration ("FDA") has given the okay to proceed for the Investigational New Drug ("IND") application for SBI-100 Ophthalmic Emulsion ("OE"). |
| 2022-11-17 | Skye Bioscience, Inc. | Regulatory Skye Bioscience Submits Investigational New Drug Application for SBI-100 Ophthalmic Emulsion to FDA skyebioscience.com ↗ |
| 2022-06-30 | Skye Bioscience, Inc. | Regulatory Skye Bioscience Receives Australian Ethics Committee Approval to Start First-in-Human Phase 1 Study of SBI-100 Ophthalmic Emulsion skyebioscience.com ↗ |
| 2022-05-05 | Skye Bioscience, Inc. | Results Skye Bioscience Reports Enhanced Intraocular Pressure-Lowering of SBI-100 Formulation Published in Peer-Reviewed Journal skyebioscience.com ↗
Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye” or the “Company”), a pharmaceutical company developing proprietary, synthetic cannabinoid derivatives to treat glaucoma and other diseases with significant unmet need, announced that the peer-reviewed journal International Journal of Pharmaceutics published preclinical data demonstrating stronger and longer-lasting reduction of intraocular pressure (IOP) when Skye’s proprietary molecule, SBI-100, is formulated as a nanoemulsion containing the mucoadhesive agent Carbopol® 940. |
| 2022-02-16 | Skye Bioscience, Inc. | Results Skye Bioscience Reports Positive Results for SBI-100 in GLP Toxicology Study skyebioscience.com ↗
No histological changes were observed in the eye and no adverse findings in remaining organs resulting from SBI-100 administration. |
| 2022-02-01 | Skye Bioscience, Inc. | Results Skye Bioscience Reports Potential Neuroprotective Benefit of SBI-100 In Preclinical Glaucoma Model skyebioscience.com ↗ |
| 2021-10-21 | Skye Bioscience, Inc. | Results Skye Bioscience Sponsored Research Presented at American Association of Pharmaceutical Scientists Meeting PharmSci 360 skyebioscience.com ↗
With THC-VHS-NEC (SBI-100), IOP remained about 20% below baseline even at 9 hours post treatment. |
All press releases naming this drug 26 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SBI-100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06144918 ↗ |