Cyclerion Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the discovery, development, and commercialization of human therapeutics. Its product pipeline includes several sGC stimulators, small molecules that act synergistically with nitric oxide on sGC to boost production of cyclic guanosine monophosphate. The company was founded on September 6, 2018 and is headquartered in Cambridge, MA.
Clinical Trials
15
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
6.7%
Completed
13
86.7%
Terminated
1
6.7%
No approval data available
- Korsana Biosciences completed its reverse merger with Cyclerion Therapeutics and closed an oversubscribed USD 380 million private placement, giving it roughly USD 475 million in pro-forma cash. - The company's lead asset, KRSA-028, is a shuttled monoclonal antibody targeting amyloid beta that uses the THETA platform to cross the blood-brain barrier via TfR1-mediated transcytosis. - Korsana expects Phase I healthy volunteer data in mid-2027 and interim proof-of-concept amyloid plaque clearance data in Alzheimer's patients by year-end 2027 or Q1 2028. - The combined cash position is expected to fund operations into 2029, and the company has expanded its leadership team with a new CMO, CTO, and board member.
- Akebia Therapeutics has dosed the first patient in a Phase 2 clinical trial evaluating praliciguat, an oral soluble guanylate cyclase stimulator, for treating focal segmental glomerulosclerosis (FSGS). - The randomized, double-blind, placebo-controlled study will enroll approximately 60 patients with biopsy-confirmed FSGS to assess changes in urine protein-to-creatinine ratio over 24 weeks. - FSGS affects approximately 40,000 patients in the U.S. with no currently approved treatments, representing a significant unmet medical need. - Praliciguat has demonstrated no significant safety issues in previous Phase 1 studies in healthy volunteers and Phase 2 studies in heart failure and diabetic kidney disease.
- Cyclerion Therapeutics announced an exclusive collaboration with Medsteer to integrate closed-loop anesthetic delivery technology into its lead program CYC-126 for treatment-resistant depression. - CYC-126 is designed as an individualized, precision-delivered treatment that combines anesthetic agents with real-time EEG monitoring and algorithm-guided dosing to target specific brain states. - The company plans to initiate a multinational Phase 2 proof-of-concept study in the second half of 2026, with first patient enrollment expected in Australia. - Medsteer's technology has been validated across more than 25 clinical settings and 9,000 patients, providing proven closed-loop anesthetic delivery capabilities.
- DelveInsight's 2025 pipeline report reveals a robust schizophrenia drug development landscape with over 55 companies advancing 60+ therapeutic candidates across various clinical stages. - Recent Phase III trials include Bristol-Myers Squibb's KarXT study in Japanese patients and Karuna Therapeutics' long-term safety extension study for adjunctive treatment. - Emerging therapies feature novel mechanisms including TAAR1 agonists, selective M4 receptor modulators, and CNS-penetrant sGC stimulators targeting unmet medical needs. - The pipeline spans multiple administration routes and molecule types, with promising candidates like Ulotaront, Emraclidine, and KarXT addressing the chronic mental disorder affecting 1% of the global population.
- Akebia Therapeutics acquired AKB-097, a tissue-targeted complement inhibitor from Q32 Bio for $7 million upfront, designed to address multiple rare kidney diseases without systemic complement inhibition. - The company initiated a Phase 2 trial of praliciguat, an oral sGC stimulator, in focal segmental glomerulosclerosis (FSGS), targeting up to 60 patients with primary endpoint of proteinuria reduction. - Both therapeutic programs are planned to begin patient enrollment in 2026, with AKB-097 Phase 2 basket trial data expected in 2027. - FSGS affects approximately 40,000 people in the U.S. with no specific treatments currently available, representing a significant unmet medical need.
- Cyclerion Therapeutics has secured intellectual property from MIT to relaunch as a neuropsychiatric company focused on treatment-resistant depression affecting 3 million Americans. - The company's lead program combines common anesthetic agents with proprietary technology to restore brain connectivity in patients with treatment-resistant depression. - A Phase 2 proof-of-concept trial is expected to begin in 2026, with initial data anticipated in 2027, marking a strategic shift from the company's previous focus on soluble guanylate cyclase stimulators. - The approach leverages known anesthetic mechanisms paired with intelligent delivery systems to pioneer a new class of neuropsychiatric therapies.
