Drugs / OK-101
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06637527 | Oct 2024 → Apr 2025 | neuropathy, painful | Okyo Pharma Ltd | Terminated | No outcome recorded |
| Phase 2 | NCT05759208 | Apr → Dec 2023 | dry eye syndrome | Okyo Pharma Ltd | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-01-23 | Okyo Pharma Ltd | Regulatory FDA Authorizes Compassionate Use of Urcosimod (0.05%) for the Treatment of Neuropathic Corneal Pain okyopharma.com ↗
Under the FDA-authorized expanded access (IND 176297), urcosimod is being provided by OKYO Pharma for use in a patient with severe neuropathic corneal pain who has limited therapeutic options and no FDA-approved treatments available. |
| 2025-12-11 | Okyo Pharma Ltd | Results OKYO Pharma Announces New Data Showing Favorable Corneal Nerve Outcomes in Phase 2 Study for Neuropathic Corneal Pain okyopharma.com ↗
Patients treated with 0.05% urcosimod demonstrated not only a positive reduction in neuropathic corneal pain, but also favorable changes in corneal nerve structure which were not observed in the placebo group. |
| 2025-07-16 | Okyo Pharma Ltd | Results OKYO Pharma Unveils Strong Phase 2 Clinical Trial Results for Urcosimod to Treat Neuropathic Corneal Pain okyopharma.com ↗
After 12 weeks of treatment, 75% of per-protocol patients receiving 0.05% urcosimod showed greater than 80% reduction in neuropathic corneal pain (NCP), as measured by Visual Analogue Scale (VAS), demonstrating highly effective treatment. |
| 2025-05-01 | Okyo Pharma Ltd | Regulatory FDA Grants OKYO Pharma Fast Track Designation to Urcosimod for Neuropathic Corneal Pain okyopharma.com ↗
announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP). |
| 2025-03-10 | Okyo Pharma Ltd | Regulatory OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain okyopharma.com ↗
Notably, neuropathic corneal pain falls into this category, and our application for Fast Track designation marks a significant milestone in our commitment to addressing the urgent needs of patients suffering from this type of pain. |
| 2024-08-06 | Okyo Pharma Ltd | Regulatory OKYO Pharma Granted European Patent Covering OK-101 Chemerin Analogs and Their Method of Use okyopharma.com ↗ |
| 2024-07-10 | Okyo Pharma Ltd | Results OKYO Pharma Announces Promising Categorical Data from OK-101 Phase 2 Trial in Dry Eye Disease okyopharma.com ↗
These analyses have identified conjunctival staining and ocular pain as the highest potential “sign” and “symptom” co-primary endpoints to be explored in the next DED trial of OK-101. |
| 2024-03-22 | Okyo Pharma Ltd | Results OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Multiple Signs and Symptoms of Dry Eye Disease including Ocular Pain Relief in its First-in-Human Phase 2 Trial of OK-101 okyopharma.com ↗
Ocular Pain Relief showed statistically significant improvement as early as day 15 and the benefit was durable throughout the trial. |
| 2024-02-09 | Okyo Pharma Ltd | Regulatory OKYO Pharma Receives FDA Approval of IND for OK-101 in Neuropathic Corneal Pain okyopharma.com ↗ |
| 2024-01-08 | Okyo Pharma Ltd | Results OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Both Sign and Symptom Endpoints in its First-in-Human Phase 2 Trial of OK-101 in Patients with Dry Eye Disease okyopharma.com ↗ |
| 2023-10-09 | Okyo Pharma Ltd | Regulatory OKYO Pharma Announces Filing of an Investigational New Drug (IND) Application for OK-101 to Treat Neuropathic Corneal Pain (“NCP”) okyopharma.com ↗
OKYO Pharma Limited (NASDAQ: OKYO), a clinical stage biopharmaceutical company developing innovative therapies for the treatment of inflammatory dry eye disease (“DED”), a multi-billion-dollar market, and for neuropathic corneal pain, a severe ocular condition with no FDA approved therapy, today announced that it filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the development of OK-101 to treat Neuropathic Corneal Pain (NCP). |
| 2023-10-05 | Okyo Pharma Ltd | Results OKYO Pharma Announces Positive Safety Data Profile for the ongoing OK-101 Phase 2 Clinical Trial to Treat Dry Eye Disease (“DED”) okyopharma.com ↗
OK-101 is well tolerated, with patients continuing on the trial without a dose change. |
| 2022-12-22 | Okyo Pharma Ltd | Regulatory OKYO Pharma Announces U.S. FDA Clearance of IND Application for OK-101 for the Treatment of Dry Eye Disease okyopharma.com ↗
“We are very pleased to receive clearance from the FDA to initiate our OK-101 Phase 2 study,” said Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma. |
| 2022-11-21 | Okyo Pharma Ltd | Regulatory OKYO Pharma Announces U.S. IND Filing on OK-101 for the Treatment of Dry Eye Disease okyopharma.com ↗
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing OK-101 to treat dry eye disease to address the significant unmet need in this multi-billion-dollar market, today announced that it filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the development of OK-101 to treat dry eye disease (DED). |
| 2022-02-23 | Okyo Pharma Ltd | Regulatory OKYO Pharma announces issuance of U.S. Patent No. 11,254,720 covering OKYO’s dry eye drug candidate OK-101 for use to treat ocular neuropathic pain okyopharma.com ↗ |
| 2021-12-14 | Okyo Pharma Ltd | Regulatory Issuance of U.S. Patent No. 11,197,906 covering OKYO Pharma’s drug candidate OK-101 for use to treat dry eye disease okyopharma.com ↗
This patent contains key claims covering OK-101 to treat dry eye disease. |
| 2021-12-13 | Okyo Pharma Ltd | Results First-in-Class Drug Candidate OK-101 Displaying Both Anti-inflammatory and Ocular Pain-Reducing Potential to Treat Dry Eye Disease okyopharma.com ↗
OK-101 was demonstrated to suppress corneal pain in a ciliary nerve ligation mouse model of neuropathic corneal pain developed in Dr. Hamrah’s laboratory. |
All press releases naming this drug 36 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OK-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05759208 ↗ |
| Action | Inhibit | “OK-101 is a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor” NCT06637527 ↗ |
| Modality | Peptide | “OK-101 is a lipid conjugated chemerin peptide antagonist” NCT06637527 ↗ |