COMPANY
Foresee Pharmaceuticals
FDA-approved therapeutic company Clinical Phase 3
Timeline
- Trial start Phase 2: Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia) source ↗
- FDA FDA Original approval: CAMCEVI ETM (leuprolide mesylate) — NDA219745, Aug 25, 2025. Applicant at approval: Foresee Pharmaceuticals Co., Ltd. source ↗
- Trial start Phase 3: Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg in Patients With Advanced Prostate Cancer source ↗
- Trial start Phase 3: Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg in Patients With Advanced Prostate Cancer source ↗
- Trial start Phase 2: Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (Windward) source ↗
- Trial start Phase 1: Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers source ↗
- Trial start Phase 1/Phase 2: A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia source ↗
- Trial start Phase 3: Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty source ↗
- Trial start 2: A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19 source ↗
- Trial start Phase 2: The Effect of FP-025, on Allergen-induced Airway Responses in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma. source ↗
- Trial start Phase 1: Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 source ↗
- Trial start Phase 3: Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer source ↗
- Trial start 1: A Phase 1, Pharmacokinetics of the MMP-12 Inhibitor FP-025 After Multiple Oral Ascending Doses in Healthy Subjects source ↗
- Trial start Phase 3: Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg source ↗
- Trial start 1: Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers source ↗
- Trial start Phase 3: Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma source ↗
Upcoming milestones
- Jan 1, 2028 (ESTIMATED) · Phase 2 · Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia) · NCT07191535
- 2028-02 (ESTIMATED) · Phase 2 · Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (Windward) · NCT06475781
Clinical trials (lead sponsor) 15
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06475781 | Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (Windward) | Phase 2 | Recruiting | Mar 1, 2025 | 2028-02 (estimated) |
| NCT07191535 | Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia) | Phase 2 | Not yet recruiting | Mar 1, 2027 | Jan 1, 2028 (estimated) |
| NCT05493709 | Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty | Phase 3 | Completed | Jun 2, 2023 | Dec 7, 2025 (actual) |
| NCT06795191 | Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg in Patients With Advanced Prostate Cancer | Phase 3 | Withdrawn | Jun 1, 2025 | Nov 30, 2027 (estimated) |
| NCT06795178 | Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg in Patients With Advanced Prostate Cancer | Phase 3 | Withdrawn | Jul 1, 2025 | Dec 31, 2027 (estimated) |
| NCT04522375 | A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia | Phase 1/Phase 2 | Withdrawn | Jun 30, 2023 | 2025-06 (estimated) |
| NCT06334211 | Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers | Phase 1 | Completed | Apr 16, 2024 | Sep 20, 2024 (actual) |
| NCT03858686 | The Effect of FP-025, on Allergen-induced Airway Responses in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma. | Phase 2 | Completed | Jul 2, 2018 | Dec 30, 2022 (actual) |
| NCT04750278 | A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19 | 2 | Terminated | Apr 6, 2021 | Apr 18, 2022 (actual) |
| NCT02238834 | Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers | 1 | Completed | 2015-06 | 2018-12 (actual) |
| NCT03686930 | Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 | Phase 1 | Completed | Feb 22, 2018 | May 27, 2018 (actual) |
| NCT03261999 | Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer | Phase 3 | Completed | Sep 26, 2017 | Nov 19, 2018 (actual) |
| NCT02712320 | Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg | Phase 3 | Completed | 2016-02 | 2017-05 (actual) |
| NCT02234115 | Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma | Phase 3 | Completed | 2014-08 | Aug 30, 2016 (actual) |
| NCT03304964 | A Phase 1, Pharmacokinetics of the MMP-12 Inhibitor FP-025 After Multiple Oral Ascending Doses in Healthy Subjects | 1 | Completed | Jul 21, 2017 | Jun 1, 2018 (actual) |
FDA records (last 2 years)
- FDA Original approval: CAMCEVI ETM (leuprolide mesylate) — NDA219745, Aug 25, 2025. Applicant at approval: Foresee Pharmaceuticals Co., Ltd. source ↗
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