Fibroblast Growth Factors (FGFs) are a family of signaling proteins that play crucial roles in various physiological processes. These proteins, comprising 22 members in humans, are involved in cell growth, proliferation, tissue repair, and embryonic development. FGFs exert their effects by binding to specific cell surface receptors, mainly tyrosine kinase receptors, initiating intracellular signaling cascades. The binding triggers a series of events, including activation of the MAPK and PI3K pathways, leading to diverse cellular responses like cell division, migration, and differentiation. FGFs are instrumental in angiogenesis, aiding in forming new blood vessels during tissue repair and development. Furthermore, they contribute to wound healing by stimulating the migration and proliferation of fibroblasts. In developmental disorders, FGFs have been implicated in skeletal and craniofacial abnormalities due to their role in embryogenesis. Conversely, abnormal FGF signaling can be linked to cancer development, as FGFs promote tumor cell proliferation, survival, and angiogenesis. Besides, FGFs' involvement in glucose metabolism and adipocyte function ties them to metabolic disorders like diabetes and obesity. The intricate role of FGFs in various biological processes makes them attractive targets for therapeutic interventions in diseases like cancer, tissue injuries, and developmental disorders. By manipulating FGF signaling, researchers aim to develop treatments that promote tissue repair, control tumor growth, and potentially address metabolic disorders. Extensive research is being conducted globally to discover new and novel molecules to be used as Fibroblast Growth Factors (FGF) to be used for the treatment of many indications of blood coagulation disorders. The development and launch of new products will thus increase the market's revenue in the forecasted years.
A number of these stimulators are in the market, while many are in ongoing clinical trials. 46 companies have about 44 products in their pipelines, with 34 products in various stages of clinical trials – 8 in Phase 4, 24 in Phase 3, and 23 in Phase 2 of the clinical trials.
Key developments of FGFs
- In August 2021, FDA approved Lenvima (lenvatinib) in combination with Keytruda (pembrolizumaab) for treating adult patients with advanced renal cell carcinoma.
- In June 2020, FDA approved Ctyssvita (burosumab-twza) fpr the treatment of patients above years of age for Tumor-induced Osteomalacia
Approved FGF molecules
- Lenvima (lenvatinib)
- Focus V (anlotinib)
- Votrient (pazopanib)
- Stivarga (regorafenib)
- Sulanda (surufatinib)
- Kepivance (palifermin)
- Crysvita (burosumab)
Drugs in the Pipeline of FGFs
- Iclusig (ponatinib)
- dovitinib (TKI258)
- Kinaction (masitinib)
- Balversa (erdafitinib)
- Pemazyre (pemigatinib)
- Retevmo (selpercatinib)
- brivanib alaninate (BMS-582664)
- Truseltiq (infigratinib)
- lucitanib (E 3810)
- fexagratinib (ABSK091)
- Lytgobi (futibatinib)
- thrombospondin-1 mimetic (ABT-510)
- Voxzogo (vosoritide)
- Gavreto (pralsetinib)
- bemarituzumab (AMG 552)
- rogaratinib (BAY 1163877)
- ENMD-2076
- Max-40279
- derazantinib (ARQ 087)
- Fiblast (trafermin)
- hydronidone (F351)
- muparfostat (PI-88)
- tasurgratinib (E7090)
- Evizon (squalamine)
- HMPL-453
- RC28-E
- recifercept (TA-46)
- Generx (alferminogene tadenovec)
- efruxifermin (AKR-001)
- gunagratinib (ICP-192)
- tinengotinib (TT-00420)
- AL8326
- FP-1039
- RBM007
- RG7444
- orantinib (TSU-68)
- vofatamab (B-701)
- Aphthasol (amlexanox)
- DVC1-0101
- HST 001
- MK-3655
- TTHX1114 intracameral injection
- fazpilodemab (BFKB8488A)
- lemon balm extract (ALS-L1023)
- zoligratinib (Debio 1347)
- AUR-109
- CBT-001
- H3B-6527
- HH185
- IONIS-FGFR4Rx
Clinical Activity and Developments of FGFs
As of July 2023, various companies have approximately 173 products for 665 diseases. For these diseases, many trials are being conducted by players globally. For instance,
- Beijing Ditan Hospital is conducting a Phase 4 clinical trial to evaluate efficacy and safety of Lenvatinib plus TACE versus Sorafenib plus TACE for Hepatocellular Carcinoma patients with Portal Vein Tumor Thrombusthat that was expected to complete by December 2022.
- Eisai Pharmaceuticals India Pvt. Ltd is conducting a Phase 4 clinical trial to s assess the safety and efficacy of Lenvatinib in subjects with Locally Recurrent or Metastatic, Progressive, Radioiodine Refractory Differentiated Thyroid Cancer that is expected to complete by May 2023.
- Sun Yat-sen University Ltd is conducting a Phase 4 clinical trial to explore the treatment of Refractory and Locally Advanced Head and Neck Malignant Tumor with Anlotinib Hydrochloride Capsules combined with chemoradiotherapy that was expected to complete by December 2022.
|
Molecule name |
Number of studies |
|
Lenvima (lenvatinib) |
410 |
|
Focus V (anlotinib) |
361 |
|
Votrient (pazopanib) |
305 |
|
Stivarga (regorafenib) |
289 |
|
Sulanda (surufatinib) |
70 |
Target Indication Analysis of FGFs
Fibroblast Growth Factors (FGFs) find extensive use in various medical indications due to their significant roles in cellular growth, tissue repair, and development. One of the primary applications of FGFs lies in promoting tissue regeneration and wound healing, making them crucial components in therapies for chronic wounds and injuries. Additionally, FGFs are utilized in angiogenesis-based treatments to stimulate the formation of new blood vessels, which can be beneficial in conditions like peripheral arterial disease and ischemic heart disease. Moreover, FGFs hold promise in bone healing and tissue engineering approaches, aiming to enhance bone repair and regeneration. FGFs have also been studied for their potential to promote hair growth and manage hair loss. Beyond regenerative medicine, FGFs have therapeutic implications in certain cancers, especially as targets for cancer treatment strategies. As researchers unravel the complexities of FGF signaling pathways, the potential applications of FGFs in various disease contexts continue to expand, offering hope for improving patient outcomes in multiple medical conditions.
FGFs Regional Analysis
Fibroblast Growth Factor (FGF) Market
Merck (MSD)’s Lenvima (lenvatinib) had net sales of $216 million in the 4th quarter of the financial year 2022, 5% more than the net sales in the 4th quarter of 2021 - $206 million. It had net sales of $876 million in the complete financial year 2022, while in the financial year 2021, the net sales were $704 million- 24% more than the financial year 2021. Novartis’s Votrient (pazopanib) had net sales of $103 million in the 4th quarter of the financial year 2022, 26% less than the net sales in the 4th quarter of 2021 - $139 million. It had net sales of $577 million in the complete financial year 2021, while in the financial year 2022, the net sales dropped by 18% to $474 million. According to the American Society of Clinical Oncology, an estimated 81,800 adults in the USA will be diagnosed with kidney cancer in 2023, making it the 6th and 9th most common cancer in the USA in men and women, respectively. In 2020, an estimated 431,288 people were diagnosed with it globally. The cases have been increasing since the past decade, which is an opportunity for the market players globally
Latin America
Europe
Asia Pacific
Middle East
North America
Frequently Asked Questions
Lenvima (lenvatinib), Focus V (anlotinib), Votrient (pazopanib) and Stivarga (regorafenib) have been approved by the FDA.
These are being used for promoting tissue regeneration and wound healing, peripheral arterial disease and ischemic heart disease and others.
Eisai, Merck (MSD), Advenchen Laboratories, Sino Biopharmaceuticals and Novartis are some of the major market players for Fibroblast Growth Factor (FGF).
Rising incidence of diseases improvement in technologies, development of new treatment lines in the market and rising incidence of various types of diseases like Renal cancer, Ischaemic Heart Disease, Peripheral Arterial Diseaases and others are the key opportunities for Fibroblast Growth Factor (FGF) in the market.
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- Eisai
- Merck (MSD)
- Advenchen Laboratories
- Sino Biopharmaceuticals
- Novartis
- Bayer
- Takeda Pharmaceuticals
- Otsuka Pharmaceutical
- Hutchmed
- Allarity Therapeutics
- Oncoheroes Biosciences
- SOBI
- AB Science
- J&J
- Incyte Pharmaceuticals
- Specialised Therapeutics
- Eli Lilly
- Ultragenyx
- Kyowa Kirin
- ZAI Lab
- BridgeBio Pharma Inc
- Pfizer
- Xediton Pharmaceuticals
- Clovis Oncology
- Servier Pharmaceuticals
- Abbisko Therapeutics
- Otsuka Pharmaceutical
- AbbVie
- BioMarin Pharmaceutical
- Blueprint Medicines
- Amgen Inc
- CASI
- Maxinovel Pharmaceuticals
- Kaken Pharma
- Catalyst Bioscience and many more