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What clinical trial data did Neurocept submit to the FDA and in what years?
Executive Summary
Neurocrine Biosciences (often conflated with the name “Neurocept” in some documents) submitted clinical trial data from two pivotal Phase 3 studies, CAH3003 (adult) and CAH2006 (pediatric), to the U.S. Food and Drug Administration as part of New Drug Applications for crinecerfont in April 2024, and the FDA approved the product (branded CRENESSITY) in December 2024; the submission and approval timeline is documented in FDA review and company announcements. Confusion in the record stems from inconsistent naming in secondary sources and unrelated filings (e.g., 510(k) device dossiers), so verification rests on the FDA review documents and Neurocrine press releases that specifically cite the CAHtalyst Phase 3 programs and NDA dates [1] [2] [3].
1. What the core claim says — a simple read of the submission narrative and trials
The central claim extracted from the materials is that clinical trial data supporting crinecerfont’s approval were drawn from two registrational studies: CAH3003 (adult Phase 3) and CAH2006 (pediatric Phase 3), and those data were included in New Drug Applications filed with the FDA in April 2024. The FDA accepted the NDAs and granted Priority Review status in mid-2024, with public statements noting acceptance in July 2024 and final approval of CRENESSITY in December 2024, which aligns with the integrated FDA review of the drug and the sponsor’s announcement of approval [1] [3] [2]. This delineation is important because regulatory determinations—acceptance, priority review, and approval—depend on the specific trials listed in the NDA.
2. Documentary evidence and timing — FDA review and company disclosures
Primary documentary evidence cited in the dataset includes an FDA integrated review that lists CAH3003 and CAH2006 and indicates that NDAs 218808 and 218820 were received in April 2024 and led to approval on December 12, 2024; company press releases corroborate submission in April 2024 and Priority Review acceptance in July 2024 [1] [3]. Peer-reviewed presentation of trial results, referenced in the press materials and media summaries, supports the clinical findings used in the regulatory decision and provides additional public validation of the trials’ endpoints and populations [2]. These multiple, converging documents—FDA review, NDAs, company announcements, and journal coverage—form the evidentiary backbone that the April 2024 submission included these two Phase 3 datasets.
3. Conflicting or extraneous records — where the name “Neurocept” muddies the trail
Some analytic excerpts and unrelated filings in the provided corpus mention “Neurocept” or list other companies, devices, or earlier-phase studies that are not part of the crinecerfont NDA record; a handful of sources appear to conflate Neurocrine with Neurocept or reference device 510(k) submissions unrelated to the drug approval [4] [5] [6] [7]. This creates the risk of misattributing FDA submissions to the wrong sponsor or mistaking device premarket notifications for drug NDAs. The authoritative documents—FDA integrated review and Neurocrine’s NDA acceptance and approval notices—identify Neurocrine Biosciences as the applicant and explicitly list the two Phase 3 CAHtalyst trials as pivotal evidence [1] [3].
4. What the trials showed and why the FDA decision followed — endpoints and safety signals
The CAH3003 and CAH2006 registrational studies evaluated crinecerfont’s effect on adrenal androgen control and glucocorticoid-sparing in adults and children with classic congenital adrenal hyperplasia, meeting primary endpoints that supported approval; the FDA review discussed efficacy measures such as reductions in androstenedione and allowed glucocorticoid dose reductions, and safety considerations including hypersensitivity and risk of adrenal insufficiency were detailed in the label and integrated review [1] [8] [2]. Regulatory weight derived from both pooled and individual-trial analyses, with the FDA concluding that benefits outweighed identified risks, giving context to the December 2024 approval. These clinical outcome summaries are present in the integrated review and company statements that accompanied the approval.
5. Bottom line for verification and lingering caveats — what to trust and what to double-check
Trust the FDA integrated review and Neurocrine’s formal communications for the definitive record that Neurocrine Biosciences submitted CAH3003 and CAH2006 data in April 2024 and received approval in December 2024; treat references to “Neurocept” or unrelated 510(k) device filings as potential noise or mislabeling that require cross-checking against FDA docket numbers and NDA identifiers [1] [3] [6]. If further precision is needed—such as redacted protocol appendices, exact submission docket contents, or individual patient-level data—consult the FDA’s public files for NDAs 218808/218820 and the cited NEJM/journal publications for full trial reports.