Médecine · English

La FDA approuvera-t-elle le relacorilant contre l'hypercortisolisme (syndrome de Cushing) ?

échéance 2026-12-17 confiance moyenne preuve niveau 1
45 %estimation Asturna

Critère de résolution

Se résout par OUI si la FDA publie une approbation (Drugs@FDA ou communiqué officiel Corcept Therapeutics) du relacorilant contre l'hypertension secondaire à l'hypercortisolisme (syndrome de Cushing) au plus tard le 17 décembre 2026. Une nouvelle lettre de réponse complète, un report de la date PDUFA ou l'absence de décision valent NON.

État de départ vérifié

A reçu une lettre de réponse complète (CRL) le 31 décembre 2025 — la FDA a jugé le critère principal de l'essai GRACE et les données confirmatoires de GRADIENT insuffisants pour une évaluation bénéfice-risque favorable sans preuves supplémentaires. Corcept a redéposé le dossier le 17 juin 2026 et attend un examen de six mois, plaçant la date d'action cible vers le 17 décembre 2026. (communiqués Corcept Therapeutics, 31 décembre 2025 et 17 juin 2026)
Les arguments ci-dessous ont été produits par le modèle en anglais. Ils sont affichés tels quels plutôt que traduits automatiquement, pour que rien sur cette page ne soit un texte que Asturna n'a pas réellement écrit.

Ce qui fait monter

Ce qui fait descendre

Ce qui ferait le plus bouger ce chiffre

Whether Corcept's re-analyzed or supplemental clinical data satisfied the FDA's efficacy concerns without triggering a three-month review extension or a second CRL.

Comment ce chiffre est fabriqué

Échéance2026-12-17
Taux de base64%
Meilleure preuveniveau 1 · 4 article(s) utilisé(s)
Estimations42 · 48 (écart 6 pts)
Confiancemoyenne
Plafond de preuvenon déclenché
Révisée le2026-10-18 09:08
Modèlegemini-3.7-flash

Sources consultées

FDA Rare Disease Innovation Hubniveau 1 · FDA · 2026-10-14FDA Rare Disease Framework Initiative Public Meeting - 10/28/2026niveau 1 · FDA · 2026-10-14FDA ‘reset’ continues with new plan for reviewing rare disease drugsniveau 4 · BioPharma Dive · 2026-10-15FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Developmentniveau 4 · U.S. Food and Drug Administration (.gov) · 2026-10-14

Historique de la probabilité

2026-10-18 09:08 45% 96 article(s) au dossier · gemini-3.7-flash
  • Ce qui fait monter. The FDA accepted the NDA resubmission on 17 June 2026 under a standard six-month review timeline [tier 1].
  • Ce qui fait monter. The FDA continues to actively emphasize regulatory flexibility in rare disease settings, as highlighted by initiatives like the Rare Disease Framework Initiative launched in October 2026 [tier 1].
  • Ce qui fait descendre. The CRL cited insufficient primary endpoint and confirmatory data for a favorable benefit-risk profile, a clinical hurdle that is difficult to overturn without new clinical trials [tier 1].
  • Ce qui fait descendre. Corcept resubmitted within less than six months of the CRL, indicating reliance on existing data re-analyses rather than new pivotal study data, which carries higher regulatory skepticism [tier 1].
  • Ce qui fait descendre. The resolution deadline strictly coincides with the estimated PDUFA date of 17 December 2026; any review postponement, major amendment adding three months, or administrative delay automatically counts as a negative resolution [tier 1].
  • Ce qui ferait le plus bouger ce chiffre. Whether Corcept's re-analyzed or supplemental clinical data satisfied the FDA's efficacy concerns without triggering a three-month review extension or a second CRL.
2026-10-17 09:10 56% 90 article(s) au dossier · gemini-3.7-flash
  • Ce qui fait monter. Corcept resubmitted the NDA on 17 June 2026 with an expected six-month Class 2 review window placing the target action date right at mid-December 2026 [tier 1].
  • Ce qui fait monter. Base rate of approvals post-CRL for NMEs provides a solid historical baseline of 64% [tier 1].
  • Ce qui fait descendre. The CRL cited clinical efficacy and benefit-risk balance concerns across the GRACE and GRADIENT trials, which are significantly harder to overcome without a new prospective trial than quality or manufacturing deficiencies [tier 1].
  • Ce qui fait descendre. The resolution criteria require approval on or before 17 December 2026; any review postponement, standard 3-month major amendment extension, or second CRL results in a NO resolution [tier 1].
  • Ce qui ferait le plus bouger ce chiffre. Whether the resubmission addressed the clinical benefit-risk concerns to FDA satisfaction without new phase 3 trial data, and whether the FDA reaches a decision on or before the 17 December 2026 cutoff without extending review.
2026-10-16 20:07 50% 90 article(s) au dossier · gemini-3-flash-preview
  • Ce qui fait monter. Corcept Therapeutics resubmitted the NDA on 17 June 2026, indicating they believe the additional evidence provided addresses the FDA's previous concerns [1].
  • Ce qui fait monter. The FDA launched a 'Rare Disease Framework Initiative' and 'Rare Disease Innovation Hub' in October 2026, signaling a potentially more supportive regulatory environment for orphan indications like Cushing's syndrome [1, 2, 28].
  • Ce qui fait descendre. The initial CRL (31 December 2025) was based on clinical data insufficiency in the primary trials (GRACE and GRADIENT), which is generally more difficult to resolve than manufacturing issues [1].
  • Ce qui fait descendre. The resolution deadline (17 December 2026) coincides exactly with the expected 6-month PDUFA date; any minor delay or a standard 3-month extension would result in a 'No' resolution [1].
  • Ce qui fait descendre. The relatively short time (5.5 months) between the CRL and resubmission suggests the 'additional evidence' may rely on re-analysis or existing data rather than new long-term clinical trials [1].
  • Ce qui ferait le plus bouger ce chiffre. Whether the specific 'additional evidence' submitted in June 2026 successfully overcomes the FDA's previous judgment that the benefit-risk assessment was unfavorable based on the GRACE and GRADIENT trials.
2026-10-14 09:08 56% 76 article(s) au dossier · gemini-flash-latest
  • Ce qui fait monter. Corcept Therapeutics successfully resubmitted the relacorilant NDA on 17 June 2026, which was accepted for a standard six-month Class 2 review with a target action date of 17 December 2026 [tier 1].
  • Ce qui fait monter. Relacorilant addresses a critical unmet need in Cushing's syndrome as a selective cortisol modulator without progesterone receptor activity [tier 1].
  • Ce qui fait descendre. The initial CRL cited fundamental efficacy and benefit-risk deficits across both the GRACE and GRADIENT studies, issues that are difficult to resolve within six months without generating new clinical trial data [tier 1].
  • Ce qui fait descendre. The resolution deadline of 17 December 2026 leaves zero calendar buffer: any standard three-month PDUFA extension for major amendments, advisory committee input, or administrative delay past that exact date resolves the question as NO [tier 1].
  • Ce qui ferait le plus bouger ce chiffre. Whether the FDA accepts Corcept's re-analyses and additional data without requiring a new prospective trial, and whether the review concludes strictly within the six-month window without an extension.
2026-10-13 12:04 54% 76 article(s) au dossier · gemini-3-flash-preview
  • Ce qui fait monter. Corcept Therapeutics resubmitted the NDA for relacorilant on 17 June 2026, indicating they have provided the additional evidence requested by the FDA [1].
  • Ce qui fait monter. The target action date (PDUFA) is expected around 17 December 2026, which aligns with the resolution deadline [1].
  • Ce qui fait descendre. The initial CRL was based on 'insufficient evidence' for a favorable benefit-risk assessment from two trials (GRACE and GRADIENT), which is a more difficult hurdle to overcome than manufacturing or labeling issues [1].
  • Ce qui fait descendre. The resolution criterion is highly sensitive to timing; any delay beyond the PDUFA date, such as the review extensions recently seen with other manufacturers, would result in a NO [2].
  • Ce qui fait descendre. The relatively short 6-month turnaround for resubmission suggests the company may be relying on re-analysis of existing data rather than new clinical trials, which the FDA may still find insufficient [1].
  • Ce qui ferait le plus bouger ce chiffre. The primary uncertainty is whether the 'additional evidence' provided in the June 2026 resubmission is robust enough to reverse the FDA's previous judgment that the trial data was insufficient for a favorable benefit-risk assessment.
2026-10-12 12:01 56% 67 article(s) au dossier · gemini-flash-latest
  • Ce qui fait monter. Corcept resubmitted the NDA on 17 June 2026 with an expected six-month Class 2 review, aligning the target action date around 17 December 2026 [tier 1].
  • Ce qui fait descendre. The CRL on 31 December 2025 specifically cited insufficient benefit-risk based on the GRACE and GRADIENT trials without additional evidence; resubmitting in less than six months means no new prospective trial could have been completed to satisfy the FDA [tier 1].
  • Ce qui fait descendre. Any standard three-month PDUFA extension or administrative postponement beyond 17 December 2026 automatically resolves the question as NO under the resolution criteria [tier 1].
  • Ce qui ferait le plus bouger ce chiffre. Whether the FDA accepts Corcept's re-analyses and existing clinical evidence without demanding a new prospective trial, and whether a decision is issued without a PDUFA extension.
2026-10-11 09:14 56% 67 article(s) au dossier · gemini-3.7-flash
  • Ce qui fait monter. Corcept successfully resubmitted the NDA on 17 June 2026 with an expected six-month Class 2 review period targeting action around 17 December 2026 [tier 1].
  • Ce qui fait descendre. The initial CRL cited core clinical efficacy and benefit-risk insufficiency from the GRACE and GRADIENT trials, which is substantially harder to resolve within 5.5 months without a new prospective trial than CMC or manufacturing deficiencies [tier 1].
  • Ce qui fait descendre. The target PDUFA date falls directly on the deadline of 17 December 2026; any standard three-month review extension, postponement, or slight timing slip resolves the question as NO under the resolution rules [tier 1].
  • Ce qui ferait le plus bouger ce chiffre. Whether Corcept's re-analyses of existing GRACE and GRADIENT data satisfy the FDA's clinical efficacy concerns without requiring new prospective trial data, and whether the review concludes on or before the strict 17 December deadline without extension.
2026-10-08 09:14 54% 50 article(s) au dossier · gemini-3-flash-preview
  • Ce qui fait monter. Corcept resubmitted the NDA on June 17, 2026, following a CRL, indicating they believe they have addressed the FDA's concerns regarding trial data [1].
  • Ce qui fait monter. The FDA accepted the resubmission for a six-month Class 2 review, suggesting the package was complete enough for a standard turnaround [1].
  • Ce qui fait monter. Corcept has significant experience in this therapeutic area, having previously secured approval for Korlym (mifepristone) for Cushing's syndrome [1].
  • Ce qui fait descendre. The initial CRL was based on 'insufficient evidence' for the primary endpoint in the GRACE trial and GRADIENT confirmatory data, which is a significant clinical hurdle to overcome without new trials [1].
  • Ce qui fait descendre. The PDUFA target action date (Dec 17, 2026) coincides exactly with the resolution deadline, meaning any minor delay or a standard three-month extension would result in a 'No' resolution [12, 28].
  • Ce qui fait descendre. The resolution criterion explicitly states that a postponement of the PDUFA date counts as a 'No', and such extensions are common in complex regulatory reviews [12, 28].
  • Ce qui fait descendre. FAERS reports 3 serious safety signals for relacorilant, which may complicate the benefit-risk assessment during the final review phase [Context].
  • Ce qui ferait le plus bouger ce chiffre. Whether the 'additional evidence' provided in the resubmission was new clinical data or just a re-analysis of the GRACE/GRADIENT trials; a re-analysis is less likely to satisfy the FDA's previous concerns about 'insufficient evidence'.
2026-10-03 09:04 64% 28 article(s) au dossier · qwen/qwen3.8-27b (Groq)
  • Ce qui fait monter. The NDA was successfully resubmitted on 17 June 2026, indicating that Corcept addressed the FDA's specific data deficiencies regarding the GRACE and GRADIENT trials [1].
  • Ce qui fait descendre. The initial CRL on 31 December 2025 cited insufficient primary endpoint and confirmatory data, suggesting a high hurdle for the resubmission to be accepted without further delay [1].
  • Ce qui ferait le plus bouger ce chiffre. Whether the additional evidence provided in the June 2026 resubmission is sufficient to overcome the FDA's previous determination that the benefit-risk assessment was unfavorable.
2026-10-02 09:09 58% 26 article(s) au dossier · openai/gpt-oss-120b (Groq)
  • Ce qui fait monter. Resubmission of the NDA on 17 June 2026 shows Corcept has added data and the FDA has set a six‑month review window, indicating progress toward a decision [tier 1]
  • Ce qui fait monter. Historical post‑CRL approval rate above 50 % suggests a better‑than‑even chance [tier 1]
  • Ce qui fait descendre. The FDA’s CRL on 31 Dec 2025 cited insufficient primary‑endpoint and confirmatory data, a strong negative signal [tier 1]
  • Ce qui fait descendre. Only a six‑month review remains; any delay would push the decision past the 17 Dec 2026 deadline, reducing the chance of approval in time [tier 1]
  • Ce qui fait descendre. Safety signals (3 serious FAERS reports) add regulatory caution, even if not decisive [context only]
  • Ce qui ferait le plus bouger ce chiffre. Whether the additional evidence submitted on 17 June 2026 will satisfy the FDA’s concerns about efficacy and benefit‑risk