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Clinical trials
catalyst calendar across sponsors →Studies where SPRB is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
7 interventional · 1 expanded access · 6 with posted results
Held by 5 tracked-famous managers (MILLENNIUM MANAGEMENT LLC, CITADEL ADVISORS LLC, Point72 Asset Management, L.P., Balyasny Asset Management L.P., RENAISSANCE TECHNOLOGIES LLC) · FINRA short interest 7.6 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Intracerebroventricular Tralesinidase Alfa in Participants With MPS IIIB (Sanfilippo Syndrome Type B)NCT07579910Change from Baseline in Bayley Scales of Infant and Toddler Development, Third Edition, Cognition Domain (BSID-III-C) Raw ScoreRandomized · Single-masked · Treatment | Phase 3 | Not yet recruiting | Drug: Tralesinidase alfa (TA) | MPS IIIB | 14 | Aug 2033 | ≤ 2,569 d | 2026-07-30 |
| A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children Aged 2-17 Years With CAHNCT05128942results2025-12-24Number of Participants With Treatment-emergent Adverse Event (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ · Informed Consent Form ↗ | Phase 2 | Terminatedsponsor's stated reason: The SPR001-203 clinical trial did not achieve the primary efficacy endpoint of the absolute change in daily GC dose from baseline at week 24. It was decided to terminate the SPR001-205 in response to the SPR001-203 efficacy data. | Drug: Tildacerfont | Congenital Adrenal Hyperplasia, 21-OHD | 67 | 2025-01-31actual | — | 2025-12-24 |
| A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAHNCT04544410results2025-10-01Change in Total Daily GC Dose in Subjects With Classic CAH Over the 24-week, Double Blind, Placebo-Controlled Treatment PeriodRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ · Informed Consent Form ↗ | Phase 2 | Terminatedsponsor's stated reason: Study did not meet its primary endpoint. | Drug: Tildacerfont/Placebo | Congenital Adrenal Hyperplasia | 100 | 2024-10-31actual | — | 2025-10-01 |
| A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAHNCT04457336results2025-07-08To Evaluate the Effect of Tildacerfont in Reducing A4 in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Over 12 WeeksRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Study SPR001-203 did not meet its primary and secondary endpoints therefore Spruce Biosciences has decided to terminate the study | Drug: Tildacerfont/Placebo | Congenital Adrenal Hyperplasia | 96 | 2024-02-09actual | — | 2025-07-08 |
| A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal AndrogensNCT05370521results2025-10-09Change in DHEASRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ · Informed Consent Form ↗ | Phase 2 | Terminatedsponsor's stated reason: The study was discontinued early by the sponsor | Drug: Tildacerfont, Placebo | Polycystic Ovary Syndrome | 27 | 2023-08-03actual | — | 2025-10-09 |
| Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal HyperplasiaNCT03687242results2025-04-01The Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) in Subjects With CAHOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SPR001 | Congenital Adrenal Hyperplasia, CAH - Congenital Adrenal Hyperplasia, CAH - 21-Hydroxylase Deficiency | 11 | 2019-07-08actual | — | 2025-04-01 |
| Study of SPR001 in Adults With Classic Congenital Adrenal HyperplasiaNCT03257462results2025-10-22Safety of SPR001 in Patients With CAHNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SPR001 | Congenital Adrenal Hyperplasia, CAH - Congenital Adrenal Hyperplasia | 24 | 2019-03-02actual | — | 2025-10-22 |
| Early Access Treatment With Tralesinidase Alfa in Mucopolysaccharidosis Type IIIB (Sanfilippo Syndrome Type B)NCT07733856expanded access | — | Available | Drug: Tralesinidase alfa (TA) | Mucopolysaccharidosis Type IIIB, MPS IIIB (Sanfilippo B Syndrome) | — | — | — | 2026-07-29 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19