This section highlights FDA-related milestones and regulatory updates for drugs developed by Cognition Therapeutics (CGTX).
Over the past two years, Cognition Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CT1812 and CT1812. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CT1812 - FDA Regulatory Timeline and Events
CT1812 is a drug developed by Cognition Therapeutics for the following indication: Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CT1812
- Announced Date:
- July 10, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, Inc., announced that it conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025.
AI Summary
On July 9, 2025, Cognition Therapeutics, Inc. held an important end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). During the meeting, the company reviewed key results from its Phase 2 study of zervimesine (CT1812), a drug candidate being developed to treat Alzheimer’s disease. The discussion focused on the data gathered from the study and the details of the proposed Phase 3 clinical trial program, which is intended to support a new drug application for zervimesine.
This FDA meeting was a crucial step for Cognition Therapeutics as it provided the company with valuable regulatory feedback on their clinical plans. The company is now preparing for the next phase of development while awaiting the official minutes from the FDA in August, which will confirm the pathway forward for zervimesine’s future testing and potential use in Alzheimer’s treatment.
Read Announcement- Drug:
- CT1812
- Announced Date:
- June 25, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that the company will conduct an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025.
AI Summary
Cognition Therapeutics, Inc. announced that it will conduct an important end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. This meeting is a key milestone for the company as it assesses the progress of its Phase 2 ‘SHINE’ study evaluating the investigational drug zervimesine (CT1812) in patients with mild-to-moderate Alzheimer’s disease.
At this meeting, the Cognition team will review the study results and discuss the proposed plans for a Phase 3 program aimed at securing regulatory approval for zervimesine. This discussion underscores the company’s commitment to advancing its clinical development efforts and exploring promising treatment options for neurodegenerative disorders. The outcome of this meeting may play a crucial role in shaping the future development of zervimesine for Alzheimer’s disease.
Read Announcement- Drug:
- CT1812
- Announced Date:
- June 3, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics announced today it has received an anonymous philanthropic donation to substantially fund an expanded access program (EAP) for people with dementia with Lewy bodies (DLB).
AI Summary
Cognition Therapeutics has received a generous anonymous donation from the family of a dementia with Lewy bodies (DLB) patient who participated in their Phase 2 SHIMMER study. This philanthropic gift will substantially fund an expanded access program (EAP) to offer zervimesine as an investigational treatment to DLB patients. Under the program, eligible patients will receive a daily dose of 100 mg of oral zervimesine for about one year. Banner Sun Health Research Institute in Arizona is the first of eight sites to open under this initiative, with Dr. Shprecher leading the site’s efforts. The donation not only supports the rapid launch of the EAP but also demonstrates a strong commitment to providing promising treatment options for people with DLB. By accelerating access to zervimesine, Cognition Therapeutics aims to make a meaningful impact on patient care and improve the quality of life for those affected by this challenging disease.
Read Announcement- Drug:
- CT1812
- Announced Date:
- May 8, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, reported topline results today from the Phase 2 COG2201 ‘MAGNIFY' trial of zervimesine (CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD).
AI Summary
Cognition Therapeutics today announced topline results from its Phase 2 MAGNIFY trial of zervimesine (CT1812) in adults with geographic atrophy (GA) caused by dry age-related macular degeneration. The trial showed that patients taking zervimesine experienced a 28.6% slower increase in GA lesion growth compared to those on placebo. In addition, at 18 months, the GA lesion area in zervimesine-treated patients was 28.2% smaller than in the placebo group. These results suggest that zervimesine, a once-daily oral pill, could offer a convenient alternative to the regular clinic visits needed for injectable treatments. The study, which enrolled about 100 participants, supports the potential for zervimesine to slow disease progression in dry AMD and possibly improve treatment options for patients who are not suited for injections.
Read Announcement- Drug:
- CT1812
- Announced Date:
- April 1, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, presented biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria.
AI Summary
Cognition Therapeutics presented new biomarker findings from its Phase 2 SHINE (COG0201) study of zervimesine in patients with mild-to-moderate Alzheimer’s disease. The results were highlighted at the AD/PD™ 2025 Alzheimer’s & Parkinson’s Diseases Conference in Vienna, Austria. Dr. Mary Hamby, VP of research, explained that the study compared changes in key proteins in the overall study group with those in a subgroup that initially had lower levels of the Alzheimer’s-related protein p-Tau217. Participants treated for six months with zervimesine showed a reduction in plasma biomarkers linked to Alzheimer’s disease. In particular, significant decreases in glial fibrillary acidic protein (GFAP) and neurofilament light (NfL) were observed. These findings suggest that zervimesine may reduce neuroinflammation and neurodegeneration, supporting its potential as a treatment option for Alzheimer’s disease.
Read Announcement- Drug:
- CT1812
- Announced Date:
- March 25, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, will be presenting biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria.
AI Summary
Cognition Therapeutics will present important biomarker results from its Phase 2 SHINE (COG0201) study at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference. The study focused on using zervimesine (CT1812) to treat patients with mild-to-moderate Alzheimer's disease. During the conference, Mary Hamby, Ph.D., the company’s VP of research, will give a podium presentation detailing the analysis of key biomarkers collected from blood samples. These biomarkers include neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), amyloid beta (Aβ), and tau species such as p-Tau217 and p-Tau218, all of which are linked to Alzheimer's disease progression.
The presentation will highlight how changes in these biomarkers in patients treated with zervimesine compare to those in patients given a placebo, adding to the understanding of the drug's potential benefits in battling Alzheimer's disease.
Read Announcement- Drug:
- CT1812
- Announced Date:
- March 20, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, provided a business update.
AI Summary
Cognition Therapeutics recently provided a business update along with its financial results for the fourth quarter and full year ended December 31, 2024. The company, which develops therapies for neurodegenerative disorders, shared that it is shifting its focus in 2025. It has concluded enrollment in its Phase 2 dry AMD study to concentrate on its planned registrational programs for Alzheimer’s disease and dementia with Lewy bodies (DLB). The update highlighted the encouraging Phase 2 data for its lead candidate, zervimesine (CT1812), which demonstrated the potential to slow cognitive decline. Looking ahead, Cognition Therapeutics plans to hold separate end-of-Phase 2 meetings with the FDA to discuss Phase 3 clinical protocols for both Alzheimer’s and DLB. Additionally, the company is reviewing options for funding its upcoming trials, including potential partnering opportunities with pharmaceutical firms to support continued clinical development.
Read Announcement- Drug:
- CT1812
- Announced Date:
- February 26, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, reported a positive outcome of an analysis of masked data from the ongoing ‘MAGNIFY' Phase 2 trial of zervimesine (also known as CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD).
AI Summary
Cognition Therapeutics announced a positive outcome from a masked futility analysis of their ongoing MAGNIFY Phase 2 trial. The study is evaluating the investigational drug zervimesine (also known as CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). Data from the first 57 participants who received at least six months of dosing revealed that patients treated with zervimesine experienced a slower rate of lesion growth compared to those on placebo.
The analysis, conducted by an independent contract research organization, was designed to assess early signals of efficacy while maintaining the trial’s integrity. The full unblinded results, including data after 12 months of dosing, are expected in the second quarter of 2025. These early findings support the potential of zervimesine to affect the underlying biological processes of dry AMD.
Read Announcement- Drug:
- CT1812
- Announced Date:
- February 26, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 - 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that Full Analysis will be Provided in the Second Quarter of 2025
AI Summary
Cognition Therapeutics, Inc. recently shared important results from its Phase 2 MAGNIFY study on zervimesine for patients with geographic atrophy from dry age-related macular degeneration. A masked futility analysis showed that participants treated with zervimesine for at least six months had a slower lesion growth rate compared to those on placebo. The study enrolled 100 participants but was ended early in order to conserve financial resources. All participants are expected to complete their final clinic visits in February 2025, after which the study data will be unblinded.
Cognition Therapeutics announced that a full analysis, including data from 12 months of dosing, will be provided in the second quarter of 2025. This upcoming analysis will offer further insights into zervimesine’s potential to alter disease progression in dry age-related macular degeneration.
Read Announcement- Drug:
- CT1812
- Announced Date:
- February 20, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that the American Chemical Society journal Organic Process Research & Development has published a manuscript describing the novel chemical process used to manufacture zervimesine (CT1812).
AI Summary
Cognition Therapeutics announced that the American Chemical Society journal Organic Process Research & Development published a manuscript detailing a novel chemical process to manufacture zervimesine (CT1812). This new process uses innovative methods such as high throughput screening and light-induced continuous flow processing to create the drug in a more efficient and safer way. It also led to the discovery of a unique polymorphic form of zervimesine, which has improved room temperature stability, meaning it can have a longer shelf life.
This breakthrough is an important step in producing enough drug material for future clinical studies and, if approved, for commercial manufacturing. Provisional patent applications have been filed to protect both the chemical process and the preferred crystal form of zervimesine.
Read Announcement- Drug:
- CT1812
- Announced Date:
- January 30, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that James E. Galvin, MD, MPH will present topline results from the ‘SHIMMER' study of zervimesine (CT1812) in dementia with Lewy bodies during an oral presentation at the International Lewy Body Dementia Conference (ILBDC).
AI Summary
Cognition Therapeutics has announced that Dr. James E. Galvin, MD, MPH, will present the topline results from the SHIMMER study at the International Lewy Body Dementia Conference (ILBDC) in Amsterdam on January 31, 2025. Dr. Galvin, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine, served as both the study director and principal investigator for this Phase 2 clinical trial, which evaluated zervimesine (CT1812) in patients with mild-to-moderate dementia with Lewy bodies (DLB).
The SHIMMER study, which enrolled 130 adults, compared zervimesine treatment to a placebo over six months. The results indicated that patients treated with zervimesine showed significant improvements across behavioral, cognitive, functional, and motor measures, suggesting it may be a promising therapeutic option for managing DLB.
Read Announcement- Drug:
- CT1812
- Announced Date:
- December 18, 2024
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced topline results from the exploratory Phase 2 ‘SHIMMER' study demonstrating CT1812 produced strong therapeutic responses across behavioral, functional, cognitive, and movement measures in patients with dementia with Lewy bodies (DLB).
AI Summary
Cognition Therapeutics announced promising topline results from their exploratory Phase 2 ‘SHIMMER’ study, showing that CT1812 produced strong therapeutic responses in patients with dementia with Lewy bodies (DLB). In this study of 130 patients with mild-to-moderate DLB, those treated with CT1812 for six months experienced significant improvements across behavioral, functional, cognitive, and movement measures compared to placebo. The findings include an 82% slowing in neuropsychiatric symptoms, with notable reductions in anxiety, hallucinations, and delusions. The study also showed a marked reduction in caregiver distress and a slowing of cognitive decline, including a 91% reduction in attention fluctuations. These positive outcomes support the further development of CT1812 and have expedited plans to advance the drug into late-stage clinical trials, with more detailed data to be presented at an upcoming international conference.
Read Announcement- Drug:
- CT1812
- Announced Date:
- November 26, 2024
- Estimated Event Date Range:
- December 1, 2024 - December 31, 2024
- Target Action Date:
- December 1, 2024
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics Topline results in second dementia indication expected to be reported in December 2024 –
AI Summary
Cognition Therapeutics, Inc. has announced an important milestone in its Phase 2 SHIMMER study evaluating CT1812 in patients with mild-to-moderate dementia with Lewy bodies. The study recently reached its completion as the final patient finished their last clinic visit. The company expects to report the topline results by December 2024, marking its second dementia indication announcement. This result will help determine the tolerability of CT1812 and provide insights into its potential benefits in improving cognitive function and overall performance in patients. The study involved careful assessments and extensive collaboration with experts and organizations committed to raising awareness of Lewy Body Dementia. The forthcoming data will contribute to a better understanding of CT1812, which is designed to address significant challenges in treating neurodegenerative disorders.
Read Announcement- Drug:
- CT1812
- Announced Date:
- November 26, 2024
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that the last patient has completed their final clinic visit in the Phase 2 SHIMMER study of CT1812 in patients with mild-to-moderate dementia with Lewy bodies (DLB).
AI Summary
Cognition Therapeutics announced that the final patient in its Phase 2 SHIMMER study of CT1812 for mild-to-moderate dementia with Lewy bodies has completed their last clinic visit. The study, which enrolled 130 adults, is assessing how the experimental drug affects cognitive and motor functions over a six‐month period. Topline results from this trial are expected in December 2024, and the data will help determine CT1812’s tolerability and potential efficacy in improving cognition and everyday functioning.
The company expressed its gratitude to the patients, caregivers, and study investigators, including partners such as the National Institute on Aging and the Lewy Body Dementia Association. This research is important as it explores new therapeutic options for dementia with Lewy bodies, a condition affecting over a million Americans and urgently in need of effective treatments.
Read Announcement- Drug:
- CT1812
- Announced Date:
- August 22, 2024
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that results from the SEQUEL study of CT1812, the Company's lead candidate for the treatment of Alzheimer's disease, were published in The Journal of Prevention of Alzheimer's Disease.
AI Summary
Cognition Therapeutics announced that the results of its SEQUEL study have been published in The Journal of Prevention of Alzheimer’s Disease. The study explored the effects of CT1812— the company's lead candidate for treating Alzheimer’s disease—by tracking changes in brain wave patterns among 16 adults with mild-to-moderate Alzheimer’s over 29 days. Participants who received CT1812 showed consistent trends of improvement across several electroencephalography (EEG) measures. Notably, there were statistically significant improvements in the central region’s relative theta power and brain connectivity markers. These findings suggest that CT1812 may help normalize brain wave patterns and facilitate better communication between different brain regions by protecting synapses. The study supports the potential of CT1812 as a unique neuroprotective treatment for Alzheimer’s disease while demonstrating a favorable safety profile with only mild to moderate side effects reported.
Read Announcement- Drug:
- CT1812
- Announced Date:
- July 26, 2024
- Estimated Event Date Range:
- July 29, 2024 - July 29, 2024
- Target Action Date:
- July 29, 2024
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announce that it will will host an investor webcast on Monday, July 29, 2024 at 8:30a.m. ET to discuss the clinical efficacy, safety and biomarker findings from the Phase 2 COG0201 "SHINE" study. SHINE enrolled 153 adults with mild-to-moderate Alzheimer's disease who were randomized to receive once-daily oral doses of CT1812 (100mg or 300mg) or placebo for six months.
AI Summary
Cognition Therapeutics will host an investor webcast on Monday, July 29, 2024, at 8:30 a.m. ET to review results from its Phase 2 COG0201 "SHINE" study. During the webcast, company management and key experts will discuss the study’s clinical efficacy, safety, and biomarker findings for CT1812. In the SHINE study, 153 adults with mild-to-moderate Alzheimer’s disease were enrolled and randomized to receive either a placebo or once-daily oral doses of CT1812 at 100 mg or 300 mg over a six‐month period. The discussion will cover various endpoints, including cognitive and functional outcomes, along with biomarker data derived from cerebrospinal fluid samples. Interested participants must register online to join the live session, with the event later available in the Investor Relations section of Cognition’s website.
Read Announcement
CT1812 (DLB) - FDA Regulatory Timeline and Events
CT1812 (DLB) is a drug developed by Cognition Therapeutics for the following indication: Dementia with Lewy bodies (DLB).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CT1812 (DLB)
- Announced Date:
- July 29, 2024
- Indication:
- Dementia with Lewy bodies (DLB)
Announcement
Cognition Therapeutics, today reported that participants in the proof-of-concept Phase 2 ‘SHINE' study (NCT03507790) who were treated with CT1812 for six months showed a consistent trend in cognitive improvement compared to placebo across all cognitive measures including ADAS-Cog 11, ADAS-Cog 13, cognitive composite and MMSE.
AI Summary
Cognition Therapeutics today announced positive findings from its proof-of-concept Phase 2 SHINE study (NCT03507790), where participants with mild-to-moderate Alzheimer’s disease received CT1812 for six months. The study showed that those treated with CT1812 experienced consistent trends in cognitive improvement compared to placebo. Key measures, including ADAS-Cog 11, ADAS-Cog 13, a cognitive composite score, and the MMSE, all indicated improvements, suggesting the drug may help slow cognitive decline.
According to study leaders, the results support the potential of amyloid oligomer antagonism as a new therapeutic mechanism. In addition to cognitive benefits, there were signals of functional improvement, reinforcing CT1812’s promise. With a favorable safety profile—most side effects being mild or moderate—the data will guide future clinical trial designs and dose selections as the company advances CT1812’s development for Alzheimer’s disease and related conditions.
Read Announcement- Drug:
- CT1812 (DLB)
- Announced Date:
- July 2, 2024
- Indication:
- Dementia with Lewy bodies (DLB)
Announcement
Cognition Therapeutics, announced that abstracts summarizing clinical efficacy, safety and biomarker findings from the Phase 2 COG0201 "SHINE" study of CT1812 have been accepted for poster presentation at the upcoming Alzheimer's Association's International Conference being held in Philadelphia, PA from July 28-August 1, 2024.
AI Summary
Cognition Therapeutics announced that abstracts summarizing clinical efficacy, safety, and biomarker findings from its Phase 2 COG0201 "SHINE" study of CT1812 have been accepted for poster presentations. These abstracts will be featured at the Alzheimer’s Association’s International Conference in Philadelphia, PA, running from July 28 to August 1, 2024. The presentation posters will highlight key results from the double-blind, placebo-controlled study, which evaluated CT1812 in adults with mild-to-moderate Alzheimer’s disease. The abstracts focus on various outcomes, including clinical performance, CSF phosphoproteomics analysis, and exploratory biomarker evaluations. In addition, the company will host a booth in the exhibit hall, offering further insights into its ongoing Alzheimer’s disease program and the development of CT1812, a drug candidate designed to target the sigma-2 receptor complex to counteract synaptic damage.
Read Announcement
