Drugs / Tildacerfont
Tildacerfont
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05370521 | May 2022 → Aug 2023 | polycystic ovary syndrome | Spruce Biosciences | Terminated | No outcome recorded |
| Phase 2 | NCT05128942 | Dec 2021 → Jan 2025 | classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency | Spruce Biosciences | Terminated | No outcome recorded |
| Phase 2 | NCT04544410 | Feb 2021 → Oct 2024 | classic congenital adrenal hyperplasia | Spruce Biosciences | Terminated | Missed primary |
| Phase 2 | NCT04457336 | Aug 2020 → Feb 2024 | congenital adrenal hyperplasia | Spruce Biosciences | Terminated | Missed primary |
| Phase 2 | NCT03687242 | Sep 2018 → Jul 2019 | classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency | Spruce Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT03257462 | Jul 2017 → Mar 2019 | congenital adrenal hyperplasia | Spruce Biosciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2024-12-10 | Spruce Biosciences | Results Spruce Biosciences Announces Topline Results from CAHmelia-204 in Adult CAH and CAHptain-205 in Adult and Pediatric CAH sprucebio.com ↗
The clinical trial did not achieve the primary efficacy endpoint of the absolute change in daily GC dose from baseline at week 24. |
| 2024-06-03 | Spruce Biosciences | Results Spruce Biosciences Presented Phase 2 POWER Study Results of Tildacerfont for the Treatment of Polycystic Ovary Syndrome at ENDO 2024 sprucebio.com ↗ |
| 2024-05-13 | Spruce Biosciences | Results Spruce Biosciences Reports First Quarter 2024 Financial Results and Provides Corporate Updates sprucebio.com ↗
In the open-label portion of the study, tildacerfont demonstrated a maximum mean reduction in adrenocorticotropic hormone (ACTH) of 45%, suggesting pituitary target engagement and direct evidence of its mechanism of action. |
| 2024-03-13 | Spruce Biosciences | Results Spruce Biosciences Reports Full Year 2023 Financial Results and Provides Corporate Updates sprucebio.com ↗
CAHmelia-203 Study of Tildacerfont in Adult Classic Congenital Adrenal Hyperplasia (CAH) with Severe Hyperandrogenemia Did Not Meet Primary Efficacy Endpoint |
| 2024-03-13 | Spruce Biosciences | Results Spruce Biosciences Announces Topline Results from CAHmelia-203 in Adult Classic CAH and CAHptain-205 in Pediatric Classic CAH sprucebio.com ↗ |
| 2024-01-05 | Spruce Biosciences | Results Spruce Biosciences Reports Baseline Characteristics from CAHmelia-203 and CAHmelia-204 Studies in Adult Classic CAH sprucebio.com ↗ |
| 2023-08-14 | Spruce Biosciences | Results Spruce Biosciences Reports Second Quarter 2023 Financial Results and Provides Corporate Updates sprucebio.com ↗ |
| 2021-06-21 | Spruce Biosciences | Results Spruce Biosciences Announces Publication of Phase 2 Results for Tildacerfont in Journal of Clinical Endocrinology and Metabolism sprucebio.com ↗ |
| 2021-05-24 | Spruce Biosciences | Results Spruce Biosciences Presents Phase 2 Data for Tildacerfont in Adults with Congenital Adrenal Hyperplasia at 23rd European Congress of Endocrinology sprucebio.com ↗
Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today presented data from its Phase 2 clinical trial of tildacerfont in adults with classic congenital adrenal hyperplasia (CAH) at the European Society of Endocrinology’s 23 rd European Congress of Endocrinology (ECE 2021), taking place virtually May 22 – 26, 2021. |
| 2021-03-17 | Spruce Biosciences | Results Spruce Biosciences Presents Phase 1 and 2 Data for Tildacerfont in Adults with Congenital Adrenal Hyperplasia from Endocrine Society’s 2021 Annual Meeting sprucebio.com ↗ |
| 2019-09-19 | Spruce Biosciences | Results Spruce Biosciences Announces Positive Results from 12-week, Phase 2a Study of Tildacerfont in Adults with Congenital Adrenal Hyperplasia sprucebio.com ↗
These included mean reductions from baseline of 74% for ACTH, 82% for 17-OHP and 55% for A4. |
| 2019-03-25 | Spruce Biosciences | Results Spruce Biosciences Achieves Proof of Concept in Phase 2 Study of Tildacerfont in Congenital Adrenal Hyperplasia sprucebio.com ↗
Across both cohorts, tildacerfont was well-tolerated, exhibited a predictable, dose-dependent pharmacokinetic profile and was effective in reducing excess A4, 17-OHP and ACTH. |
| 2019-03-08 | Spruce Biosciences | Results Spruce Biosciences Announces Presentation of Positive Topline Data from Phase 2 Study of Tildacerfont (SPR001) in Congenital Adrenal Hyperplasia at the 2019 Annual Meeting of the Endocrine Society (ENDO) sprucebio.com ↗
We are pleased to be in a position to share positive data from our Phase 2 program, which demonstrated that tildacerfont was well-tolerated and effective in reducing ACTH and adrenal steroids. |
| 2017-12-04 | Spruce Biosciences | Regulatory Spruce Biosciences Receives FDA Orphan Drug Designation for SPR001 for the Treatment of Congenital Adrenal Hyperplasia sprucebio.com ↗ |
| 2017-01-05 | Spruce Biosciences | Regulatory Spruce Biosciences Receives EMA Orphan Drug Designation for SPR001 for the Treatment of Congenital Adrenal Hyperplasia sprucebio.com ↗
San Francisco – January 5, 2017 – Spruce Biosciences , a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders, today announced that the European Medicines Agency (EMA) has granted orphan drug designation for SPR001 for the treatment of congenital adrenal hyperplasia (CAH). |
All press releases naming this drug 17 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tildacerfont | “Tildacerfont in Adults With Classic Congenital Adrenal Hyperplasia: Results from Two Phase 2 Studies.” PMID 34146101 ↗ Oct 2021 |
| Known as | LY-2371712 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095198 ↗ |
| Known as | SPR001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03687242 ↗ |
| Action | Inhibit | “Tildacerfont, a corticotropin-releasing factor type-1 receptor antagonist, may reduce excess androgen production” PMID 34146101 ↗ Oct 2021 |
| Modality | Small molecule | — CHEMBL5095198 ↗ |
| Route | Oral | “Tildacerfont administered daily via oral tablet” NCT04457336 ↗ |