Inhibikase Back In Game As FDA Lifts Hold On Multiple System Atrophy Drug

The US FDA lifted a clinical hold that it had placed in November after reviewing the company’s INDs to start Phase IIa studies in MSA and Parkinson’s, which was the subject of a hold lifted in January.

The FDA lifted a full clinical hold on Inhibikase's MSA program • Source: Shutterstock

Inhibikase Therapeutics, Inc. is back in the race to develop a drug to treat multiple system atrophy (MSA) now that the US Food and Drug Administration has lifted a full clinical hold on IkT-148009, after having already lifted the hold for Parkinson’s disease.

The company announced on 8 March that the FDA had lifted the hold it placed on its investigational new drug...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Schrödinger Drops CDC7 Inhibitor SGR-2921 After Two Patient Deaths

 

The drug is one of multiple candidates in the class that have been pulled from development, though it is not the company’s lead candidate.

Vedanta’s Live Bacteria Reach A Dead End In Ulcerative Colitis

 

The microbiome-based company’s trial of VE202 in ulcerative colitis has failed in Phase II, but its ongoing Phase III study in C difficile infection is more promising.

Xenon Nears Phase III Readout For Potential Epilepsy And Depression Blockbuster

 

Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.

Another Day Another Win For Novartis’s Ianalumab – This Time In ITP

 
• By 

The Swiss drugmaker’s BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate has chalked up another win in late-stage development, further strengthening its pipeline-in-a-product bid.

More from R&D

Xenon Nears Phase III Readout For Potential Epilepsy And Depression Blockbuster

 

Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.

Another Day Another Win For Novartis’s Ianalumab – This Time In ITP

 
• By 

The Swiss drugmaker’s BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate has chalked up another win in late-stage development, further strengthening its pipeline-in-a-product bid.

Pfizer/Astellas’s Padcev Scores First Big Win In Bladder Cancer Study

 

The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.