Sunday, September 7, 2025

PharmaTher Submits For Phase 2 Clinical Trial With FDA

PharmaTher Holdings (CSE: PHRM) is looked to complete a phase two clinical trial. The company this morning announced the submittal of an investigational new drug application with the US FDA for its drug focused on levodopa-induced dyskinesia in patients with Parkinson’s disease.

The phase two clinical trial will look to evaluate the safety, efficacy, and pharmacokinetics in the use of what is referred to as low-dose ketamine for the stated indication. More specifically, the trial is titled as, “A Multi-Center, Phase IIA, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease.

The company will look to conduct the clinical trials across up to eight sites across the US, with an initial 36 test subjects. The main item focused on by the company is what is known as the “Unified Dyskinesia Rating Scale,” which the company will look to raise to a score of “Week 8” from “Baseline”. Ketamine is currently an FDA-approved drug that is used most commonly as an anesthetic agent.

“The submission of our IND application with the FDA is an important milestone as it provides us with a solid foundation to advance our ambition in commercializing ketamine and unlocking its therapeutic potential through novel uses, formulations and delivery methods in the treatment of neurodegenerative diseases (ie. Parkinson’s disease and Lou Gehrig’s disease), mental illness (ie. Depression and PTSD) and chronic pain.”

Fabio Chianelli, CEO of PharmaTher

Assuming positive results are received from the clinical trial, the company has indicated that it will request a meeting with the FDA. That meeting is set to discuss a plan and reach an agreement to move to a phae 3 clinical trial.

PharmaTher last traded at $0.245 on the CSE.


FULL DISCLOSURE: Pharmather is a client of Canacom Group, the parent company of The Deep Dive. The author has been compensated to cover Pharmather on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security.

Video Articles

Goliath Resources Hits 10.60 g/t Gold Over 22.82 Metres, Highest Grade Results In Third Distinct Rock Package At Surebet Discovery

Four Countries Control the Fertilizer That Feeds the World | Sage Potash

$10,000 Gold Is Just A Question of Time | Florian Grummes

Recommended

ESGold Outlines $24.3 Million NPV For Tailings Reprocessing Project

First Majestic Encounters 711 g/t Silver Equivalent Over 8.0 Metres In Ongoing Exploration At Los Gatos

Related News

PharmaTher To Commence Phase 2 Clinical Study On Ketamine In Q2 2021

Pharmather Inc (CSE: PHRM) is successfully progressing on the development of its proposed phase 2...

Thursday, February 4, 2021, 08:28:04 AM

PharmaTher Collaborates For Research On Psychedelic Microdosing Tech

PharmaTher Inc (CSE: PHRM) this morning announced that it will be conducting further research related...

Tuesday, February 23, 2021, 07:25:33 AM

Pharmather Enters Exclusive Arrangement For Psychedelic Delivery Tech

Pharmather Inc (CSE: PHRM) this morning announced that it has entered into an exclusive license...

Thursday, October 22, 2020, 08:13:19 AM

PharmaTher Licenses Patented Microneedle Delivery Tech For Ketamine

PharmaTher Inc (CSE: PHRM) this morning announced that it has entered into an exclusive worldwide...

Monday, February 1, 2021, 08:13:56 AM

PharmaTher Acquires Exclusive Rights To Patented Ketamine Formulation

PharmaTher Inc (CSE: PHRM) has entered into an exclusive worldwide license agreement for the development...

Tuesday, January 19, 2021, 09:24:20 AM