The patent issuance removes near-term IP risk for CTx-1301 and supports a longer commercial runway. Monitor for FDA regulatory milestones (NDA filing under 505(b)(2) pathway) and potential partnership or out-licensing interest in the ADHD asset.
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Executive Summary
Cingulate announced the USPTO issued its first company-owned U.S. patent (No. 12,653,791) for lead ADHD asset CTx-1301, covering formulation and method-of-use claims through December 2042. This extends exclusivity on the company's most advanced pipeline candidate and strengthens its intellectual property position ahead of potential commercialization.
Key Facts
- USPTO issued U.S. Patent No. 12,653,791 on June 16, 2026, covering CTx-1301's formulation and method of use through December 2042.
- This is the first U.S. patent owned wholly by Cingulate for CTx-1301.
- Patent includes composition-of-matter, formulation, structural, and method-of-treatment claims for the trimodal Precision Timed Release tablet.
- Cingulate also holds patents in 30 European territories, Australia, Canada, and Israel, with applications pending in Hong Kong and South Korea.
Financial Impact
Patent extends market exclusivity for lead asset CTx-1301 through 2042, potentially protecting a multi-hundred-million-dollar ADHD market opportunity (US ADHD market ~100 million annual prescriptions). No financial terms disclosed.
Risk Factors
- CTx-1301 is still in clinical development and not yet FDA-approved; regulatory or clinical setbacks could impair value.
- Company is pre-revenue with a $66M market cap; financing risk remains high for a clinical-stage biotech.
- Patent validity could be challenged by competitors in the ADHD space.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-028815 |
| Exhibit: ex99-1.htm | 0001493152-26-028815 |
| Document: 0001493152-26-028815-index-headers.html | 0001493152-26-028815 |
| Document: 0001493152-26-028815-index.html | 0001493152-26-028815 |
| Document: 0001493152-26-028815.txt | 0001493152-26-028815 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 2, 2026 23d ago | 8-K | $4.75 | awaiting T+60 | — | $4.98 (+4.84%) |
Sep 22, 2026 4w ago | Institutional Cluster | $5.15 | awaiting T+60 | — | $4.98 (−3.21%) |
Aug 13, 2026 10w ago | 8-K | $4.99 | awaiting T+60 | — | $4.98 (−0.20%) |
Jul 14, 2026 14w ago | 8-K | $4.71 $4.87 | ▲ +3.40% | ▲ +0.02% | $4.98 (+5.73%) |
Jun 16, 2026 18w ago | 8-K | $4.74 $5.17 | ▲ +9.07% | ▲ +8.07% | $4.98 (+5.06%) |
Jun 8, 2026 19w ago | Insider Cluster | $4.65 $5.15 | ▲ +10.75% | ▲ +6.94% | $4.98 (+7.10%) |
Mar 25, 2026 30w ago | EFFECT | $6.36 $4.97 | ▼ −21.86% | ▼ −35.31% | $4.98 (−21.70%) |
Mar 23, 2026 31w ago | S-3/A | $6.93 $5.12 | ▲ +26.12% | ▲ +39.18% | $4.98 (+28.14%) |
Mar 18, 2026 31w ago | DEFA14A | $7.51 $4.93 | ▼ −34.35% | ▼ −48.70% | $4.98 (−33.69%) |
Mar 18, 2026 31w ago | 8-K | $8.04 $5.09 | ▼ −36.69% | ▼ −48.22% | $4.98 (−38.06%) |
US Market Status
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