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Pipeline Overview SIF NCE

Stabilized Injectable Formulation (SIF)

CAMCEVI (Leuprolide, FP-001)

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • Prostate Cancer, CAMCEVI 42 mg

  • Prostate Cancer, CAMCEVI 21 mg

  • Central Precocious Puberty

  • Premenopausal Breast Cancer (Note 1)

FP-014 (Triptorelin)

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • Prostate Cancer

FP-016 (Undisclosed)

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • Neurology/Psychiatry

FP-017 (Undisclosed)

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • Neurology/Psychiatry

Note 1 : This Phase 3 clinical trial has been initiated by GeneScience Pharmaceuticals, Foresee's licensing partner in China.
Note 2 : FP-004 (Buprenorphine) and FP-011 (Goserelin) are immediately available for partnering.

New Chemical Entities (NCE)

Aderamastat (FP-025, MMP-12 Inhibitor)

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • POC Phase 2 study in allergic asthma patients

  • Cardiac Sarcoidosis

Linvemastat (FP-020, MMP-12 Inhibitor)

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • Asthma or COPD

  • Inflammatory bowel disease (IBD)

FP-MMP-12 inhibitor 1

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • ILD, including Idiopathic pulmonary fibrosis (IPF)

FP-MMP-12 inhibitor 2

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • Neurology

Mirivadelgat (FP-045, ALDH2 Activator)

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD) (solid formulation)

FP-ALDH2 Activator 1

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • Cardiovascular, Renal and Metabolic Diseases (CVRM)

FP-ALDH2 Activator 2

  • Product / Indication
  • Research
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III
  • NDA/MAA
  • Market

  • Neurology

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CAMCEVI (Leuprolide, FP-001)

CAMCEVI® is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI® is the first leuprolide product that comes as a prefilled syringe requiring no mixing, with a satisfactory shelf life. CAMCEVI® 42 mg Injectable emulsion is administered subcutaneously every 6 months.

CAMCEVI® 42 mg (6-month LAI formulation) is now approved in the U.S., Canada, EU, Taiwan, Israel and the UK and launched in the U.S. and Germany in April 2022 and January 2025, respectively. Additionally, the MAA of CAMCEVI 6-month was submitted to the China NMPA by GeneScience Pharmaceuticals, Foresee's licensing partner in China, and accepted for a substantive review.


The global, multi-national, multi-center Phase 3 clinical trial for the 3-month version of CAMCEVI was successfully completed and the results were announced in 2019 with 97.9% of the subjects achieved primary efficacy endpoint. CAMCEVI ETM (Every Three Months) was approved by the U.S. FDA on August 25, 2025, while the EU regulatory review for the 3-month version of CAMCEVI is still ongoing.

Learn more about CAMCEVI® at: https://www.camcevihcp.com/


FP-001 42 mg is the first leuprolide product that comes as a prefilled syringe requiring no mixing for the potential treatment of Central Precocious Puberty (CPP). FP-001 42 mg Injectable emulsion is administered subcutaneously every 6 months and has the potential of becoming the first prefilled ready-to-use 6-month long-acting leuprolide for the treatment of CPP.

A multicenter, multinational Phase 3 Casppian study is ongoing. The Phase 3 clinical trial will evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg-controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). 

Learn more about Casppian study at: https://clinicaltrials.gov/ct2/show/NCT05493709?term=Foresee+Pharmaceuticals&draw=2&rank=6 (Identifier: NCT05493709)

Aderamastat (FP-025, MMP-12 Inhibitor)

Aderamastat (FP-025) is a first-in-class highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases.

Aderamastat has successfully completed a Phase 2 allergic asthma proof-of-concept (PoC) study in 2023 with positive outcomes, with future development in rare immune-fibrotic diseases.

Foresee is planning the initiation of a Phase 2 cardiac sarcoidosis study in 2025.

FP-014 (Triptorelin)

FP-014 is a ready-to-use, subcutaneous, long-acting injectable dosage form, administered either every three months or six months, thereby reducing the frequency of administration to patients to ensure better compliance.

Triptorelin is a common palliative treatment for men with advanced or metastatic prostate cancer. It is also prescribed for the treatment of breast cancer, precocious puberty, endometriosis or uterine fibroids, etc.

The 3 and 6 month ready-to-use, long-acting injectable formulations are ready for multicenter, multinational Phase 3 clinical studies in advanced prostate cancer (KATANA studies).

Linvemastat (FP-020, MMP-12 Inhibitor)

Linvemastat (FP-020) is a new-generation, best-in-class, oral MMP-12 inhibitor developed by Foresee. Linvemastat displays better pharmaceutical properties and higher potency and similar high selectivity to aderamastat. Linvemastat has shown excellent results in asthma, idiopathic pulmonary fibrosis, interstitial lung disease, inflammatory bowel disease and sarcoidosis animal models. 

Linvemastat represents a unique “pipeline-in-a-product” opportunity that has the potential to capture multibillion US dollar markets as it becomes an anchor product across the immune-fibrotic disease segment and beyond.

Linvemastat, for which a Phase 1 SAD/MAD trial in healthy volunteers in Australia has been successfully completed with promising safety, tolerability and pharmacokinetic Profile. In the meantime, the supporting chronic GLP toxicology studies are ongoing, with the objective of initiating Phase 2 studies in both moderate to severe asthma and IBD in 2025.

FP-016 (Undisclosed)

FP-016 is a ready-to-use, subcutaneous, long-acting injectable dosage form targeting sustained and stable plasma and CNS concentrations of active drug for the treatment of neurological diseases. 

Monthly, subcutaneous injections reduces the frequency of administration to patients and can also help address the need of patients that have difficulties with oral dosing, thereby improving patient compliance.

This program, which has the potential of transforming the treatment landscape in its therapeutic category, is at IND-enabling stage.

FP-MMP-12 inhibitor 1

Building on the success of FP-025 (aderamastat) and FP-020 (linvemastat) as well as remarkable translational data, Foresee intends to select distinct development candidates emerging from separate patents with very strong and long composition of matter protection (LOE: 2041 and beyond) for further development in ILD.

The role of MMP-12 in ILD is increasingly well established which we intend to explore with new Development Candidates in the future.

FP-017 (Undisclosed)

Foresee is currently conducting extensive research and development to identify and select SIF-LAI Development Candidates in the neurology / psychiatry area.

Foresee is seeking to develop FP-017, LAIs of oral antipsychotics currently highly successful in the market, but where there are currently no LAI equivalents in development (as far as we know) or on the market.

LAI reduces the frequency of administration to patients and can also help address the need of patients that have difficulties with oral dosing, thereby improving patient compliance.

This program, which has the potential of transforming the treatment landscape in its therapeutic category, is at preclinical stage.

FP-MMP-12 inhibitor 2

Building on the success of FP-025 (aderamastat) and FP-020 (linvemastat) as well as remarkable translational data, Foresee intends to select distinct development candidates emerging from separate patents with very strong and long composition of matter protection (LOE: 2041 and beyond) for further development in neurology.

New emerging biology is supporting an important role of MMP-12 in the establishment of various neurological conditions which we intend to explore with new Development Candidates in the future.

Mirivadelgat (FP-045, ALDH2 Activator)

Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2.

There is compelling biology supporting the role of ALDH2 activation as a unique therapeutic approach for PH that may be, based on preclinical data, disease-modifying via improvement of lung (interstitial fibrosis), heart and pulmonary artery function.

Mirivadelgat pediatric formulation has successfully completed single and multiple ascending dose Phase 1 studies, a 28-day repeat dose Phase 1 study, and 3-month GLP toxicology studies. 

Foresee is planning to initiate a Phase 2 study in pulmonary hypertension associated with interstitial lung diseases (PH-ILD) patients in 1Q2025 with an oral dosing formulation (WINDWARD study). 

Learn more about WINDWARD study at: 

https://clinicaltrials.gov/study/NCT06475781?term=Foresee%20Pharmaceuticals%20Co.,%20Ltd.&rank=5 (Identifier: NCT06475781)

FP-ALDH2 Activator 1

Building on the success of FP-045 (mirivaldegat) as well as remarkable translational data, including recent publications in high profile journals such as Nature Communications, Foresee intends to select distinct development candidates emerging from separate patents with very strong and long composition of matter protection (LOE: 2044 and beyond) for further development in CVRM diseases.

The role of ALDH2 in CVRM diseases is increasingly well established, which we intend to explore with new Development Candidates in the future.

FP-ALDH2 Activator 2

Building on the success of FP-045 (mirivaldegat) as well as remarkable translational data, Foresee intends to select distinct development candidates emerging from separate patents with very strong and long composition of matter protection (LOE: 2044 and beyond) for further development in neurology.

The emerging biology is supporting an important role of ALDH2 in the establishment of various neurological conditions, such as amyotrophic lateral sclerosis (ALS), which we intend to explore with new Development Candidates in the future.