Drugs / Lucid-21-302
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | — | 2026-05-28 | “U.S. Food and Drug Administration ("FDA") addressing the matters identified in the clinical hold letter relating to Lucid-MS (Lucid-21-302)” issuerdirect.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06595706 | Sep 2024 → Jan 2025 | — | Huge Biopharma Australia Pty Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05821387 | Mar → Jul 2023 | — | Quantum Biopharma | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-09-10 | Quantum Biopharma | Regulatory Historic First in MS Treatment Could Reshape a Multibillion-Dollar Therapeutics Market issuerdirect.com ↗
Quantum BioPharma Ltd. (NASDAQ: QNTM) ( profile ) has received U.S. Food and Drug Administration (“FDA”) clearance to launch a phase 2 trial of Lucid-MS , a patented, first-in-class candidate designed not to calm the immune system but to shield, and potentially rebuild, the myelin sheath itself. |
| 2026-09-08 | Quantum Biopharma | Regulatory A Micro-Cap Biotech Just Cleared a Milestone Most Never Reach issuerdirect.com ↗
The FDA's clearance of Quantum BioPharma's Investigational New Drug (“IND”) application marks a genuinely rare moment in MS research. |
| 2026-08-10 | Quantum Biopharma | Regulatory Quantum BioPharma Receives United States FDA Clearance To Proceed with Lucid-MS Phase 2 Trial in Progressive Multiple Sclerosis: issuerdirect.com ↗ |
| 2026-06-01 | Quantum Biopharma | Regulatory Quantum BioPharma Provides Corporate Update issuerdirect.com ↗
On May 28, 2026, the Company received correspondence from the U.S. Food and Drug Administration (“FDA”) indicating that the IND has been placed on clinical hold pending submission of additional information requested by the agency. |
| 2026-05-07 | Quantum Biopharma | Regulatory Quantum Reports Strengthened Liquidity, Reduced Cash Burn, and Disciplined Cost Management in First Quarter 2026 issuerdirect.com ↗
The Company announced that it has formally submitted an IND |
| 2026-04-01 | Quantum Biopharma | Regulatory Quantum BioPharma Submits Investigational New Drug (IND) Application to United States Food and Drug Administration (FDA) for Lucid-MS Phase Two Clinical Trial in Multiple Sclerosis issuerdirect.com ↗
today announced that it has formally submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lucid-21-302 (Lucid-MS), its new drug candidate for the treatment of multiple sclerosis (MS). |
| 2025-08-05 | Quantum Biopharma | Results Quantum Biopharma Announces Positive Results of the Clinical Study Report (CSR) for the Phase 1 Multiple Ascending Dose (MAD) Clinical Trial of Experimental Multiple Sclerosis Drug Lucid-21-302 (Lucid-MS) issuerdirect.com ↗
The CSR concludes that there were no safety or tolerability concerns that were identified in healthy participants following treatment with consecutive daily dosing of Lucid-MS. |
| 2025-07-08 | Quantum Biopharma | Regulatory Quantum BioPharma Submits its Candidate Breakthrough Patented Drug for Multiple Sclerosis for Fast-Track Program in the United Kingdom issuerdirect.com ↗
The ILAP Passport application was submitted for Lucid-21-302 as a new, first-in-class treatment for multiple sclerosis (MS). |
| 2025-02-26 | Quantum Biopharma | Results Quantum Biopharma Announces Completion of the Phase 1 Multiple Ascending Dose Clinical Trial for its Experimental Multiple Sclerosis Drug Lucid-21-302 issuerdirect.com ↗
The SRC found that Lucid-21-302 “(Lucid-MS”) was well-tolerated with no safety concerns and no serious adverse events were reported during the trial. |
| 2024-06-27 | Quantum Biopharma | Regulatory FSD Pharma Receives Ethics Committee Approval for a Phase-1 Multiple Ascending Doses Clinical Trial for Lucid-21-302 (Lucid-MS) in Australia issuerdirect.com ↗ |
| 2024-05-07 | Quantum Biopharma | Regulatory FSD Pharma Submits a Phase-1 Multiple Ascending Doses Clinical Trial Application for Lucid-21-302 (Lucid-MS) for Ethics Committee Review in Australia issuerdirect.com ↗
This clinical trial application is submitted for review by a human ethics review committee (HREC) in Australia, a step that is necessary to obtain permission to initiate the multiple ascending dose (MAD) trial. |
| 2024-03-05 | Quantum Biopharma | Results FSD Pharma Presents Positive Results on First-In-Human Phase-1 study of Lucid-21-302 (Lucid-MS) at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2024 Forum issuerdirect.com ↗
The study concluded that Lucid-21-302 is safe and well-tolerated in the dose range of 50-300 mg p.o. administered once, with no difference in pharmacokinetics between the fed and fasted states. |
| 2023-09-18 | Quantum Biopharma | Results FSD Pharma announces Interim Results from First-in-Human Clinical Trial of Lucid-MS (Lucid-21-302) for Multiple Sclerosis; The Report Shows Compound to be Safe and Well Tolerated issuerdirect.com ↗
Lucid-21-302 was demonstrated to be safe and well-tolerated in single oral doses in healthy volunteers. |
| 2023-02-09 | Quantum Biopharma | Regulatory InvestmentPitch Media Video Discusses FSD Pharma's Receipt of No Objection Letter from Health Canada for Clinical Trials for LUCID-21-302 for MS issuerdirect.com ↗
The Letter of No Objection covers the company’s proposed Phase 1 clinical trial of LUCID-21-302 or Lucid-MS, a novel drug candidate for the treatment of Multiple Sclerosis and provides FSD Pharma with regulatory approval to move forward with the clinical trial in Canada. |
| 2023-02-07 | Quantum Biopharma | Regulatory FSD Pharma Receives Regulatory Clearance for Its Proposed Phase-1 Clinical Trial of Lucid-21-302 (Lucid-MS), First-in-Class Multiple Sclerosis Drug Candidate issuerdirect.com ↗
The NOL provides FSD Pharma with regulatory approval to move forward with the clinical trial in Canada. |
| 2023-01-17 | Quantum Biopharma | Regulatory FSD Pharma submits its phase-1 Clinical Trial Application for Lucid-MS (Lucid-21-302) for first-in-human safety and tolerability investigation issuerdirect.com ↗
FSD Pharma submits its phase-1 Clinical Trial Application for Lucid-MS (Lucid-21-302) for first-in-human safety and tolerability investigation |
| 2021-12-02 | Quantum Biopharma | Results FSD Pharma Unveils Videos Demonstrating Positive Effects of Lucid-MS in Treating Multiple Sclerosis in Pre-Clinical Models (Mouse Models) issuerdirect.com ↗
FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9) (“ FSD Pharma ” or the “ Company ”), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced today that it is sharing pre-clinical data, supported by an explanatory video, demonstrating the potentially disease-modifying effects of Lucid-MS, the Company’s lead drug candidate for the potential treatment of multiple sclerosis (“MS”), in the animal models of MS. |
All press releases naming this drug 26 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 | Lucid-21-302 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06595706 ↗ |
| Action | Inhibit | “A small molecule inhibitor of hypercitrullination” NCT05821387 ↗ |
| Modality | Small molecule | “A small molecule inhibitor of hypercitrullination” NCT05821387 ↗ |