Debio 4326

Debio 4326 is a unique injectable, biodegradable 12-month extended-release formulation of triptorelin in development for the treatment of Central precocious puberty (CPP). The product has been designed to further reduce the frequency of injections, particularly lightening the treatment administration burden for children affected by this rare disorder. Based on favorable efficacy and safety data from currently marketed triptorelin 1-, 3- and 6-month formulations, this new formulation aims to provide improved long-term compliance and reduced stress for children and their parents.

Product Snapshot


Decreases serum gonadotropin and sex hormone levels

Being researched in:

  • Central Precocious Puberty (CPP)

In short

Debio 4326 stems from Debiopharm’s internal innovation and will offer the possibility of lightening the treatment administration burden for children affected by CPP

Phase 3, LIBELULA, study (NCT06129539) carried out in North and South America aims to demonstrate the efficacy and safety of triptorelin 12-month formulation.

About Central Precocious Puberty (CPP)

Central precocious puberty (CPP) is caused by the premature activation of the hypothalamic-pituitary-gonadal axis. This early activation can be due to specific genetic alterations, central nervous system lesions and social stressors but frequently has no identified etiology [1]. The approximative prevalence of CPP is 1 in 5,000-10,000, more frequent in girls than in boys globally [2-4]. Precocious puberty is characterized by the accelerated manifestation of secondary sex characteristics, accelerated growth and bone maturation before the age of 8 years in girls and before 9 years in boys [5-6]. including increased risk of metabolic complications, such as type 2 diabetes, weight gain, obesity, cardiovascular disease, as well as depression, and even premature death [7-12]. Early puberty has also been associated with increased risk of breast cancer in women. In men it may increase the risk of prostate cancer [13-15].


[1] Maione L, et al. Clin Endocrinol (Oxf). 2021 Oct;95(4):542-555. doi: 10.1111/cen.14475. Epub 2021 Apr 20. PMID: 33797780; PMCID: PMC8586890.
[3] Abreu AP, Kaiser UB. Lancet Diabetes Endocrinol. 2016;4(3):254–264. [PubMed: 26852256]
[3] Partsch CJ, Sippell WG. Hum Reprod Update. 2001;7(3):292–302. [PubMed: 11392376]
[4] Soriano-Guillen L, et al. J Clin Endocrinol Metab. 2010;95(9):4305–4313. [PubMed: 20554707]
[5] Latronico AC, et al. Lancet Diabetes Endocrinol. 2016;4(3):265–274. [PubMed: 26852255]
[6] Sanctis V, et al. Acta biomedica: Atenei Parmensis. 2019 90 (3): 345-359.
[7] Day FR, et al. 2015. Sci Rep, 5: 11208.
[8] Elks CE, et al. 2013. Diabetes Care, 36 (11): 3526-34.
[9] Prentice P, and Viner RM. 2013. Int J Obes (Lond), 37 (8): 1036-43
[10] Ong KK, et al. 2012. J Clin Endocrinol Metab, 97 (8): 2844-52.
[11] Hamlat EJ, et al. 2014. J Abnorm Child Psychol, 42 (4): 527-38.
[12] Charalampopoulos D, et al. 2014. Am J Epidemiol, 180 (1): 29-40.
[13] Day FR, et al. 2017. Nat Genet, 49 (6): 834-41.
[14] Bonilla C, et al. 2016. BMC Med, 14: 66.
[15] Bräuner EV, et al. 2020. JAMA Netw Open, 3 (10): e2015665.