Cingulate Inc
cingulate.comWhat Do They Do?
Develops timed-release drug candidates for people with ADHD and anxiety, using a tablet technology designed to release medicine at set times.
10-K for FY2025, filed Mar 18, 2026We are a biopharmaceutical company using our proprietary Precision Timed ReleaseTM (“PTRTM”) drug delivery platform technology to build and…View ↗
Our two proprietary, first-line stimulant medications: CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), are being developed…View ↗
We have also embarked on a program to develop CTx-2103 (buspirone), for the treatment of anxiety, which is one of the most common mental…View ↗
How Do They Make Money?
No revenue reported yet.
10-K for FY2025, filed Mar 18, 2026
How Are They Changing?
- Net income
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Sources
10-Q for Q2 FY2026, filed Aug 13, 2026
−$5.9MView ↗
- ▲ +18% (Loss)
- vs −$5M in Q2 FY2025
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Jun 2, 2026
FDA requests additional manufacturing information for CTx-1301
The letter identified specific manufacturing information requests and raised no current concerns about clinical safety or efficacy.
Sources
8-K, filed Jun 2, 2026
On June 2, 2026, the Company announced that the FDA has issued a CRL for its New Drug Application for CTx-1301. The FDA identified specific…View ↗
Licensing geography
The older report described licensing product candidates to third parties for use outside the United States; the latest report also includes licensing for use in the United States.
10-K for FY2022, filed Mar 10, 2023 10-K for FY2025, filed Mar 18, 2026Out-license our PTR platform to other companies and license our product candidates outside of the United States. We evaluate opportunities…View ↗
Out-license our PTR platform to other companies and license our product candidates in the United States and internationally. We may seek…View ↗
Who Do They Compete With?
Competes with Janssen, Novartis, Takeda, Aytu, Tris, Corium, Collegium, and Rhodes
10-K for FY2025, filed Mar 18, 2026If approved, both CTx-1301 and CTx-1302 will compete against currently marketed, branded, and generic methylphenidate and amphetamine…View ↗
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