Drugs / RISVODETINIB
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold multiple system atrophy 1 milestone | |||||
| Clinical hold | US (FDA) | — | multiple system atrophy | 2022-11-07 | “received the U.S. Food and Drug Administration's (FDA) clinical hold letter in regards to the Company's IkT-148009 programs in Parkinson's disease and Multiple System Atrophy.” inhibikase.com ↗ “has issued a Clinical Hold on the IkT-148009 201 program in Parkinson's disease (PD) and the use of IkT-148009 in MSA.” inhibikase.com ↗ |
| Clinical hold Parkinson disease 1 milestone | |||||
| Clinical hold | US (FDA) | — | Parkinson disease | 2022-11-07 | “received the U.S. Food and Drug Administration's (FDA) clinical hold letter in regards to the Company's IkT-148009 programs in Parkinson's disease and Multiple System Atrophy.” inhibikase.com ↗ “These participants were withdrawn from the trial following the FDA’s temporary clinical hold in November, 2022 that was lifted in January, 2023.” inhibikase.com ↗ “has issued a Clinical Hold on the IkT-148009 201 program in Parkinson's disease (PD) and the use of IkT-148009 in MSA.” inhibikase.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06641557 | Feb → Mar 2023 | — | ABLi Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT05424276 | May 2023 → Oct 2024 | Parkinson disease | ABLi Therapeutics, Inc. | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT06644326 Comparator | Jun 2023 → Aug 2024 | — | ABLi Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04350177 Comparator | Feb 2021 → Oct 2022 | Parkinson disease | ABLi Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2023-10-16 | Inhibikase Therapeutics | Results Inhibikase Therapeutics Highlights Unblinded Functional Analysis from the 201 Trial of Risvodetinib in Untreated Parkinson’s Disease and Provides Update on Ongoing Enrollment inhibikase.com ↗
The primary endpoints were safety and tolerability and no participant experienced any clinically significant adverse events. |
| 2023-10-04 | Inhibikase Therapeutics | Regulatory Inhibikase Therapeutics Receives FDA Orphan Drug Designation for Risvodetinib for the Treatment of Multiple System Atrophy inhibikase.com ↗
today announced that risvodetinib (IkT-148009) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Multiple System Atrophy (MSA). |
| 2023-03-08 | Inhibikase Therapeutics | Regulatory Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Multiple System Atrophy inhibikase.com ↗
With the clinical hold lifted and the IND now open, we look forward to completing these studies prior to initiation of the Phase 2a trial in this patient population. |
| 2023-01-25 | Inhibikase Therapeutics | Results Inhibikase Therapeutics Announces Publication Demonstrating Potential for c-Abl as a Key Therapeutic Target in Parkinson's Disease and Related Disorders inhibikase.com ↗
The publication also highlights data from once daily oral administration of IkT-148009 in multiple animal models that mimicked the rate of disease progression found in human PD. |
| 2023-01-25 | Inhibikase Therapeutics | Regulatory Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Parkinson's Disease inhibikase.com ↗
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the U.S. Food and Drug Administration ("FDA" or "Agency") has lifted the full Clinical Hold on IkT-148009 in Parkinson's disease (PD). |
| 2022-12-07 | Inhibikase Therapeutics | Regulatory Inhibikase Therapeutics Provides Update to FDA Clinical Hold of IkT-148009 Programs inhibikase.com ↗
announced that it has received the U.S. Food and Drug Administration's (FDA) clinical hold letter in regards to the Company's IkT-148009 programs in Parkinson's disease and Multiple System Atrophy. |
| 2022-11-07 | Inhibikase Therapeutics | Regulatory Inhibikase Therapeutics Announces FDA Clinical Hold on IkT-148009 Programs inhibikase.com ↗
The FDA indicated it will provide an official clinical hold letter to Inhibikase within 30 days. |
| 2022-09-15 | Inhibikase Therapeutics | Results Inhibikase Therapeutics to Present Data from Phase 1/1b study of IkT-148009 at the Movement Disorders Society Congress inhibikase.com ↗
These data highlight that IkT-148009 is safe and well tolerated over 7-days of daily dosing, with high systemic exposure and persistent penetration into the CNS in both healthy volunteers and patients with Parkinson's disease. |
| 2022-06-13 | Inhibikase Therapeutics | Regulatory Inhibikase Therapeutics Announces Advancement of IkT-148009 Phase 2 '201' Program Following FDA Review inhibikase.com ↗
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced that it is advancing its Phase 2a study ('201 trial') following review of the study protocol and Phase 1/1b ('101 trial') data by the U.S. Food and Drug Administration (FDA or 'the Agency'). |
| 2022-03-08 | Inhibikase Therapeutics | Results Inhibikase Therapeutics to Present Phase 1/1b Clinical Data at the Upcoming AD/PD™ Alzheimer's & Parkinson's Diseases Conference inhibikase.com ↗
The Phase 1 study, which was initiated in February 2021, demonstrated high levels of drug exposure in the blood with no clinically significant adverse events observed across 88 subjects in single and/or 7-day dosing up to 250 mg. |
| 2021-10-04 | Inhibikase Therapeutics | Results Inhibikase Therapeutics Announces Interim Three-month Results from Chronic Toxicology Studies of its Oral c-Abl Kinase Inhibitor, IkT-148009, in Development for Treatment of Parkinson's Disease inhibikase.com ↗
Today's update includes interim results at three months from both animal species, across which the toxicology profile for IkT-148009 improved the longer the drug was dosed. |
| 2021-07-26 | Inhibikase Therapeutics | Regulatory Inhibikase Therapeutics Receives FDA Clearance To Begin Evaluation of IkT-148009 in Parkinson's Patients inhibikase.com ↗
Following the review, the Agency met with the Company on July 22, 2021, and granted the company permission to begin evaluation of IkT-148009 in Parkinson's patients. |
| 2021-02-22 | Inhibikase Therapeutics | Results Inhibikase Therapeutics to Present at the American Society of Experimental Neurotherapeutics (ASENT) Conference inhibikase.com ↗
Inhibikase's President and Chief Executive Officer, Milton Werner, Ph.D. will describe the benefits observed following therapeutic, oral, daily administration of IkT-148009 in humanized mouse models of slowly progressive Parkinson's disease (PD). |
| 2019-02-26 | Inhibikase Therapeutics | Regulatory Inhibikase Therapeutics Files Two Investigational New Drug Applications for IkT-148009, a Disease-Modifying Therapy for Parkinson’s Disease inhibikase.com ↗
today announced that it has filed two Investigational New Drug (IND) applications with the U.S. Food and Drug Administration (FDA) to initiate human clinical trials of IkT-148009, a cellular Abelson tyrosine kinase (c-Abl) inhibitor for Parkinson’s Disease (PD) and related disorders. |
All press releases naming this drug 23 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RISVODETINIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314481 ↗ |
| Known as | IkT-148009 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06644326 ↗ |
| Known as | IKT148009 SUCCINATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314481 ↗ |
| Known as | RISVODETINIB SUCCINATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314481 ↗ |
| Action | Inhibit | “selective inhibitor of the nonreceptor Abl kinases” PMID 41721133 ↗ Feb 2026 |
| Modality | Small molecule | — CHEMBL5314481 ↗ |
| Route | Oral | “Oral administration gelatin capsule” NCT04350177 ↗ |
| Target | ABL1 | “selective inhibitor of the nonreceptor Abl kinases c-Abl1 and c-Abl2/Arg” PMID 41721133 ↗ Feb 2026 |
| Target | ABL2 | “selective inhibitor of the nonreceptor Abl kinases c-Abl1 and c-Abl2/Arg” PMID 41721133 ↗ Feb 2026 |