Last reviewed · How we verify
NCT05493709
An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients With Central (Gonadotropin-Dependent) Precocious Puberty (Casppian Study)
Phase 3 trial testing Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide in Puberty; Precocious, Central in 93 participants. Participants enrolled and being followed up; not accepting new ones.
1 November 2025
Quick facts
| Lead sponsor | Foresee Pharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 93 |
| Start date | 2 June 2023 |
| Primary completion | 1 November 2025 |
| Estimated completion | 1 June 2026 |
| Sites | 41 locations across United States, China, Puerto Rico, Taiwan |
Drugs / interventions tested
- Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide — full drug profile →
Conditions studied
- Puberty; Precocious, Central — all drugs for Puberty; Precocious, Central →
Sponsor
Foresee Pharmaceuticals Co., Ltd. — full company profile →
Who can join
Adults 2 to 9, any sex, with Puberty; Precocious, Central. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Efficacy of Leuprolide Mesylate (FP-001 42 mg)
Time frame: 48 weeks
The percentage of patients with serum LH concentrations \< 4 mIU/mL 60 minutes following an abbreviated GnRHa stimulation test at Visit 6 (Week 24).
Sponsor's own description
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05493709
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Foresee Pharmaceuticals Co., Ltd. trials
Trials by the same sponsor.
- NCT07191535 — Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia) · Phase 2 · not yet recruiting
- NCT06795178 — Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg in Patients With Advanced Prostate Cancer · Phase 3 · withdrawn
- NCT06795191 — Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg in Patients With Advanced Prostate Cancer · Phase 3 · withdrawn
- NCT06334211 — Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers · Phase 1 · completed
- NCT04750278 — A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19 · Phase 2, PHASE3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05493709 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Foresee Pharmaceuticals Co., Ltd.
- Last refreshed: 17 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05493709.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing