Has Neurocept received any FDA designations or IND approvals in 2023 or 2024?

1. Why the question matters and the immediate finding that stands out

The question targets whether Neurocept achieved formal FDA regulatory milestones—designations (e.g., Fast Track, Breakthrough) or IND approvals—in 2023–2024. The documentation provided contains no affirmative statement that Neurocept received such regulatory actions during that period. The company’s own product information emphasizes manufacture in an FDA-registered facility and positions the product as a dietary supplement, a regulatory status that does not require pre-market FDA approval and does not equate to IND clearance or therapeutic designations ^{[1] [2]}. Independent lists of novel FDA approvals for 2023 and 2024 compiled in the materials likewise do not include Neurocept ^{[3] [4]}.

2. What Neurocept’s own materials explicitly say—and what that implies

Neurocept’s official site text in the supplied set makes two relevant points: the product is sold as a dietary supplement and is manufactured in an FDA-registered facility, but the site does not claim any FDA therapeutic designation or IND authorization ^[1]. Under U.S. law, dietary supplements are not subject to FDA pre-market approval like drugs; registration of a facility is distinct from approval of a product for clinical use. Therefore, the company’s own disclosures in these sources are consistent with no drug-related regulatory milestones reported in 2023–2024 ^{[1] [2]}.

3. Independent regulatory and approval lists reviewed show no mention of Neurocept

The analytical corpus includes consolidated lists of FDA novel drug approvals for 2023 and 2024 and a special report on neurology approvals; none of these listings reference Neurocept or an IND for it ^{[3] [4] [5]}. The materials do include examples of other companies receiving FDA designations—such as a breakthrough therapy designation for latozinemab in early 2024—illustrating that the compilation captures notable FDA actions when present, but Neurocept is not among them in the supplied records ^[6].

4. Name confusion and information gaps that could mislead readers

One source in the packet refers to Neurocatch Inc. FDA filings, which is a different entity and illustrates a potential source of confusion when checking regulatory records ^[7]. The provided analyses note that the Neurocatch entry does not clarify Neurocept’s status and the dataset lacks explicit Neurocept filings. This ambiguity underscores a gap: the reviewed sources are comprehensive for many approvals, but they do not include direct FDA IND documents or press releases from Neurocept confirming any 2023–2024 designations or IND approvals ^{[7] [3]}.

5. How to reconcile the evidence and what remains unconfirmed

Based on the available materials, the most defensible conclusion is that there is no evidence within these sources that Neurocept received FDA designations or IND approvals in 2023 or 2024. That does not prove an absolute negative beyond these documents—absence from the supplied lists and the company’s dietary-supplement framing strongly suggest no drug-related approvals occurred, but confirmation would require a direct check of FDA records or a primary company statement. The existing sources collectively point to no documented regulatory milestone for Neurocept in the reviewed timeframe ^{[1] [2] [3]}.

6. Bottom line and practical next steps for verification

The provided evidence supports the clear, direct statement: No record in this dataset shows Neurocept received FDA designations or IND approvals in 2023 or 2024. To remove any remaining uncertainty, seek primary regulatory records—FDA announcement pages, IND filing databases, or an official Neurocept press release—but note that within the materials provided here, Neurocept’s positioning as a dietary supplement and its absence from the 2023–2024 approval compilations constitute the strongest available evidence ^{[1] [3] [4]}.