This section highlights FDA-related milestones and regulatory updates for drugs developed by SciSparc (SPRC).
Over the past two years, SciSparc has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ibogaine and SCI-110. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Ibogaine - FDA Regulatory Timeline and Events
Ibogaine is a drug developed by SciSparc for the following indication: For Pioneering Ibogaine Combination Therapy.
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:
- Ibogaine
- Announced Date:
- September 16, 2024
- Indication:
- For Pioneering Ibogaine Combination Therapy
Announcement
SciSparc Ltd. announced that as part of its ongoing collaboration with Clearmind Medicine Inc a biotechnology company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated mental health problems, the publication of an international patent application under the Patent Cooperation Treaty for the innovative combination of Ibogaine with N-Acylethanolamines.
AI Summary
SciSparc Ltd., in partnership with Clearmind Medicine Inc., has reached a key milestone by publishing an international patent application under the Patent Cooperation Treaty. This patent covers an innovative treatment that combines Ibogaine—derived from the Tabernanthe iboga shrub—with N-Acylethanolamines, a group of molecules including compounds like Palmitoylethanolamide. Ibogaine has shown promise in early studies for treating substance use disorders, including opioid and cocaine addiction.
The collaboration aims to enhance the safety and efficacy of treatments for mental health and addiction issues by integrating psychedelic-derived therapeutics with lipid-based molecules. This breakthrough marks a significant step toward offering more effective treatment options for patients battling under-treated mental health challenges, reinforcing both companies’ commitment to pioneering novel therapies in these fields.
Read Announcement
SCI-110 - FDA Regulatory Timeline and Events
SCI-110 is a drug developed by SciSparc for the following indication: For the treatment of Tourette Syndrome ("TS").
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:
- SCI-110
- Announced Date:
- September 30, 2024
- Indication:
- For the treatment of Tourette Syndrome ("TS").
Announcement
SciSparc Ltd. announced that the U.S. Food and Drug Administration ("FDA") has confirmed that its investigational new drug ("IND") application for its first in class drug candidate SCI-110 study may proceed with its Phase IIb clinical trials in the U.S. in adults patients with Tourette Syndrome ("TS").
AI Summary
SciSparc Ltd. announced that the U.S. Food and Drug Administration (FDA) has confirmed its investigational new drug (IND) application for its first in class drug candidate SCI-110. This confirmation allows the company to move forward with Phase IIb clinical trials in the U.S. for adult patients suffering from Tourette Syndrome (TS). SCI-110 is designed to address the unmet medical need in TS treatment by offering a therapy with both higher efficacy and improved safety compared to current medications. The upcoming study will evaluate the drug’s effectiveness and safety over a period, focusing on the reduction of tic severity. This milestone marks an important step for SciSparc, as the company aims to provide patients with a treatment that can potentially manage a broader range of TS symptoms while ensuring a favorable safety profile.
Read Announcement- Drug:
- SCI-110
- Announced Date:
- September 23, 2024
- Indication:
- For the treatment of Tourette Syndrome ("TS").
Announcement
SciSparc Ltd. announced that the U.S. Food and Drug Administration ("FDA") has confirmed that its investigational new drug ("IND") application for its first in class drug candidate SCI-110 study may proceed with its Phase IIb clinical trials in the U.S. in adults patients with Tourette Syndrome ("TS").
AI Summary
SciSparc Ltd. announced that the U.S. Food and Drug Administration (FDA) has confirmed its investigational new drug (IND) application for the study of its first in class drug candidate, SCI-110, in adults with Tourette Syndrome (TS). With this clearance, the Phase IIb clinical trials can now proceed in the United States. These trials aim to evaluate the efficacy, safety, and tolerability of SCI-110 as a daily oral treatment in patients aged 18 to 65 years.
The FDA's swift confirmation of the IND application is a significant milestone for SciSparc. It demonstrates regulatory confidence in advancing SCI-110 for TS and supports the company’s commitment to developing innovative therapies for central nervous system disorders. This progress brings new hope for adults suffering from TS who require safe and effective treatment options.
Read Announcement- Drug:
- SCI-110
- Announced Date:
- September 18, 2024
- Indication:
- For the treatment of Tourette Syndrome ("TS").
Announcement
SciSparc Ltd. announced that it has taken a major step forward with its proprietary SCI-110 for the treatment of Tourette Syndrome ("TS"), with its submission of an Investigational New Drug application to the U.S. Food
AI Summary
SciSparc Ltd. has taken a major step in its search for Tourette Syndrome treatments by submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration. This submission supports the upcoming Phase IIb clinical trial of its proprietary drug candidate, SCI-110, which is designed to treat TS symptoms in adult patients. The trial will be conducted at three renowned centers: Yale Child Study Center in the United States, Hannover Medical School in Germany, and Tel Aviv Sourasky Medical Center in Israel, all of which have secured the necessary institutional and regulatory approvals. This move highlights SciSparc’s commitment to advancing research on central nervous system disorders and may pave the way for new, effective treatment options for individuals suffering from Tourette Syndrome.
Read Announcement - Drug:
- SCI-110
- Announced Date:
- August 23, 2024
- Indication:
- For the treatment of Tourette Syndrome ("TS").
Announcement
SciSparc Ltd. announced the submission of an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for its phase IIb clinical trial for its proprietary SCI-110 for the treatment of Tourette Syndrome ("TS").
AI Summary
SciSparc Ltd. has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase IIb clinical trial of its proprietary drug candidate, SCI-110, designed to treat Tourette Syndrome (TS). SCI-110 combines dronabinol and palmitoylethanolamide, and the company believes it could offer a significant improvement over current TS treatments. The IND submission marks an important step toward evaluating the drug’s efficacy, safety, and tolerability in adult patients, and it reflects the company’s commitment to addressing the challenges associated with TS.
The clinical trial will take place at leading research centers, including the Yale Child Study Center (USA), Hannover Medical School (Germany), and Tel Aviv Sourasky Medical Center (Israel). This multicenter study could pave the way for a new treatment option for Tourette Syndrome if the trial results prove favorable.
Read Announcement
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