imatinib prodrug (IkT-001Pro) / Inhibikase - LARVOL DELTA

A Phase 2 Study of IkT-001Pro in Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Inhibikase Therapeutics | N=150 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: ABLi Therapeutics, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Dec 2024

Trial completion • Trial completion date

Parkinson’s Disease New Drug Development Fails in Series… Inhibikase Discontinues ’Risvodetinib’ and Focuses on PAH [Gogole trnaslation] (The Bio) - P2 | N=120 | NCT05424276 | Sposnor: Inhibikase Therapeutics, Inc. | "On the 30th (local time), American pharmaceutical company Inhibikase Therapeutics...announced that it will discontinue the development of 'risvodetinib (development code name IkT-148009),' a new drug candidate for Parkinson's disease in phase 2 clinical trials. Instead, Inhibikase plans to focus on its other major development program, 'IkT-001Pro (development code name)...risbodetinib met the primary efficacy objectives in terms of safety and tolerability in the phase 2 clinical trial, but lacked the primary functional improvement effect. Inhibicase plans to present additional analysis results at a future academic conference...The clinical results showed that lisbodetinib showed a similar frequency and severity of side effects compared to the placebo group after 95% of participants completed the 12-week treatment, indicating no issues related to safety and tolerability."

Discontinued • P2 data • Parkinson's Disease • Pulmonary Arterial Hypertension

A Phase 2 Study of IkT-001Pro in Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Inhibikase Therapeutics, Inc.

New P2 trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Inhibikase Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2024 ➔ Sep 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Enrollment closed • Trial completion date • Trial primary completion date

Inhibikase Therapeutics Announces Full Outcomes of its Pre-NDA Meeting with the FDA for IkT-001Pro (GlobeNewswire) - "Inhibikase Therapeutics, Inc...today announced preliminary outcomes of the Company’s discussion with the U.S. Food and Drug Administration (FDA) on the path to approval of IkT-001Pro in blood and stomach cancers, the Company’s prodrug of the anticancer agent imatinib mesylate....In the minutes, the FDA noted that it may not be necessary to conduct a formal use-related risk analysis of medication errors due to the Company proposing dosage forms that would not overlap with those of imatinib mesylate. In the NDA package, the Company will have to justify why its alternate dosage forms could overcome the risk of dosing errors by physicians and patients."

FDA event • Gastric Cancer • Hematological Malignancies • Oncology • Solid Tumor

Inhibikase Therapeutics Announces Preliminary Outcomes of its Pre-NDA Meeting with the FDA on the Pathway for Approval for IkT-001Pro in Blood and Gastrointestinal Cancers (GlobeNewswire) - "Inhibikase Therapeutics, Inc...announced preliminary outcomes of the Company’s discussion with the U.S. Food and Drug Administration (FDA) on the path to approval of IkT-001Pro in blood cancers, the Company’s prodrug of the anticancer agent imatinib mesylate....During the meeting Inhibikase inquired whether additional clinical studies may be needed to seek approval and discussed manufacturing and quality control requirements for approval....These preliminary outcomes from the meeting are subject to formal review of the NDA package."

FDA event • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Inhibikase Therapeutics Granted Pre-NDA Meeting with the FDA for IkT-001Pro (GlobeNewswire) - "Inhibikase Therapeutics...announced the U.S. Food and Drug Administration has granted a pre-New Drug Application (pre-NDA) meeting to be held in January 2024 to discuss the requirements for approval of IkT-001Pro and to review the data establishing doses of IkT-001Pro bioequivalent to 400 mg and 600 mg imatinib mesylate. The Company expects to provide an update following the meeting....Pre-NDA Meeting to discuss requirements for a 505(b)(2) NDA submission for IkT-001Pro in up to eight blood and stomach cancer indications. Bioequivalence to 400 mg and 600 mg imatinib mesylate completed with minimal adverse events."

FDA event • Gastrointestinal Cancer • Hematological Malignancies

A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Inhibikase Therapeutics, Inc. | Trial completion date: Nov 2023 ➔ Mar 2024 | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date

Inhibikase Therapeutics Announces Completion of the 501 Bioequivalence Study of IkT-001Pro (PRNewswire) - P1 | N=64 | NCT05623774 | Sponsor: Inhibikase Therapeutics, Inc.| "Inhibikase Therapeutics, Inc...today announced the completion of its bioequivalence study of IkT-001Pro compared to 400 mg imatinib mesylate....Imatinib delivered by IkT-001Pro demonstrated a slower rise time to maximum plasma concentration (Tmax) of 6 hours, compared to the 4-hour Tmax of 400 mg imatinib mesylate, but displayed lower inter-patient variability relative to standard-of-care. Mean and median maximum plasma concentration (Cmax) and overall exposure (AUC0-infinity) were approximately 16% higher for IkT-001Pro relative to 400 mg imatinib mesylate, consistent with higher total imatinib delivery by 600 mg IkT-001Pro."

P1 data • PK/PD data • Trial completion • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Inhibikase Therapeutics Announces Selection of the Bioequivalent Dose of IkT-001Pro and Provides Update on the '501' Bioequivalence Study (PRNewswire) - "On-track to complete pivotal clinical phase of the 501 study by the end of 2Q22...Inhibikase Therapeutics, Inc...today announced that it has selected the bioequivalent dose of IkT-001Pro, the Company's prodrug formulation of imatinib mesylate designed to enhance the safety and efficacy of imatinib (marketed as Gleevec®) in patients with Chronic Myelogenous Leukemia (CML) and provided an update on its '501' bioequivalence study. The '501' bioequivalence study has evaluated IkT-001Pro at four single ascending doses of 300, 400, 500 and 600 mg, leading to the selection of 600 mg IkT-001Pro as the bioequivalent dose to 400 mg imatinib mesylate. The pivotal phase of the study was dosed with bioequivalent IkT-001Pro in 31 healthy volunteers; one subject was excluded pre-dose due to aberrant clinical laboratory values. The Company expects to complete the pivotal clinical phase of the study by the end of the second quarter."

Trial completion date • Trial status • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Inhibikase Therapeutics to Host Virtual R&D Event on March 22, 2023 (PRNewswire) - "Inhibikase Therapeutics, Inc...announced that it will host a virtual R&D Event on Wednesday, March 22, 2023 at 11:00 am ET....The Company will round its presentation with the status of IkT-001Pro, a prodrug formulation of imatinib mesylate which is currently being evaluated in a bioequivalence study for Chronic Myelogenous Leukemia."

Clinical data • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Inhibikase Therapeutics Provides Interim Update on the '501' Bioequivalence Study of IkT-001Pro (PRNewswire) - P1 | N=64 | NCT05623774 | Sponsor: Inhibikase Therapeutics, Inc. | "As of March 15, 2023, the Company has enrolled 19 of 27 healthy volunteers in the dose calibration portion of the study, completing 3 of 4 planned escalating doses at 300, 400 and 500 mg IkT-001Pro. To date, IkT-001Pro has shown a favorable safety profile, with only 4 mild adverse events observed, none of clinical significance. IkT-001Pro has high oral bioavailability and a pharmacokinetic profile of delivered imatinib that closely matches the exposure of imatinib delivered as 400 mg imatinib mesylate. Upon completion of the dose escalation phase, the Company will conduct a confirmatory analysis of the bioequivalent dose of IkT-001Pro in 32 additional healthy volunteers...The Company remains on track to complete the 501 trial in the second quarter of 2023….following the completion of the 501 trial, Inhibikase plans to initiate a discussion with the FDA on the parameters for approval of IkT-001pro..."

P1 data • Trial completion date • Trial status • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Inhibikase Therapeutics, Inc. | Trial completion date: May 2023 ➔ Nov 2023

Trial completion date • Chronic Myeloid Leukemia

Inhibikase Therapeutics Announces Dosing of First Subjects in its '501' Bioequivalence Study of IkT-001Pro (PRNewswire) - "Inhibikase Therapeutics...announced the dosing of the first three subjects in its '501' bioequivalence study of IkT-001Pro, the Company's prodrug formulation of imatinib mesylate designed to enhance the safety and efficacy of imatinib (marketed as Gleevac®) in patients with Chronic Myelogenous Leukemia (CML). IkT-001Pro will be evaluated in a single ascending dose bioequivalence study and will enroll approximately 56 male and female healthy volunteers aged 25 to 55 who will receive IkT-001Pro at one of four doses....Following this study, Inhibikase plans to conduct a superiority study comparing the selected dose of IkT-001Pro to 400 mg imatinib mesylate....'We look forward to completing this study in the first half of 2023'..."

New trial • Trial completion date • Trial status • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Inhibikase Therapeutics, Inc.

New P1 trial • Chronic Myeloid Leukemia

Inhibikase Therapeutics Announces FDA Clearance of Investigational New Drug Application for IkT-001Pro for the Treatment of Chronic Myelogenous Leukemia (PRNewswire) - "Inhibikase Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has reviewed its Investigational New Drug (IND) application for IkT-001Pro for the treatment of Chronic Myelogenous Leukemia (CML) and issued a Study May Procced (SMP) letter. IkT-001Pro is a prodrug formulation of imatinib mesylate and has been developed to improve the safety of the first FDA-approved Abelson (Abl) kinase inhibitor, imatinib (marketed as Gleevec®)."

IND • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Inhibikase Therapeutics Reports First Quarter 2021 Financial Results and Highlights Recent Period Activity (PRNewswire) - "Initiated clinical batch manufacturing and pill formulation of IkT-001Pro...better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia (CML). Inhibikase expects to file an Investigational New Drug (IND) application in the third quarter of 2021, with initiation of clinical development as soon as practicable after the filing, subject to FDA acceptance of the IND."

IND • Chronic Myeloid Leukemia • Hematological Malignancies • Oncology