What are the main drug classes in the female infertility pipeline?

The female infertility drug pipeline spans recombinant FSH preparations (follitropin alfa, follitropin delta), small-molecule FSH receptor allosteric agonists (e.g., TOP5668, TOP5300), GnRH agonist and antagonist protocols, kisspeptin analogs for ovulation triggering, IL-17 adjuvants for in vitro oocyte maturation, IL-1 inhibitors for ovarian reserve protection, and regenerative approaches including intraovarian platelet-rich plasma and stem cell therapies.

What is the role of Anti-Müllerian Hormone (AMH) in fertility treatment?

AMH serves two roles in fertility medicine. As a diagnostic biomarker, serum AMH and antral follicle count (AFC) are the strongest predictors of poor and hyper-ovarian response in controlled stimulation cycles, outperforming basal FSH, LH, and estradiol. As a therapeutic target, recombinant AMH is being investigated to protect the primordial follicle pool from chemotherapy-induced depletion (oncofertility), and AMH levels are used to guide FSH starting dose selection in individualized stimulation protocols.

What are oral small-molecule FSH receptor agonists and how far along are they?

Oral small-molecule FSH receptor agonists are non-peptidic allosteric agonists that activate the FSH receptor without requiring injection. Compounds TOP5668 and TOP5300, described by researchers at Baylor College of Medicine, achieved efficacy comparable to recombinant hFSH in CHO cell in vitro models and have IND-enabling pharmacokinetic, drug metabolism, and safety profiles. These compounds are currently at the preclinical stage; no clinical trial data have been retrieved.

What is kisspeptin's role in ovarian stimulation and how advanced is its development?

Kisspeptins are central neuroendocrine regulators capable of eliciting an endogenous LH surge for final oocyte maturation, positioning them as next-generation alternatives to hCG or GnRH agonist triggers. Sumitomo Pharma Switzerland GmbH filed two pending IL patents in 2024 claiming a specific kisspeptin-analog peptide for promoting oocyte maturation in IVF, reducing OHSS, and improving pregnancy rates, with specific claims covering PCOS patients and women with AMH >15 pmol/L. Development stage is estimated as late preclinical to Phase I/II based on patent content.

What is progestin-primed ovarian stimulation (PPOS) and what are its advantages?

Progestin-primed ovarian stimulation (PPOS) uses medroxyprogesterone acetate (MPA) or dydrogesterone instead of GnRH analogs to suppress premature LH surge during controlled ovarian stimulation. When combined with corifollitropin alfa (a long-acting FSH), PPOS protocols reduce the number of injections and clinic visits while maintaining LH suppression. Retrospective data from Taiwan suggest non-inferiority versus antagonist protocols in normal and high responders, with all-freeze embryo transfer used to address the progesterone effect on endometrial receptivity.

What does intraovarian platelet-rich plasma (PRP) injection show in clinical trials?

A registered prospective clinical trial conducted at the University of Westminster (N=182 patients) found that intraovarian injection of activated autologous PRP resulted in AMH improvement in 28% of treated patients, with a median AMH increase of 167%. This approach is being evaluated as a pre-COS priming strategy for patients with diminished ovarian reserve. No regulatory approval for this modality has been identified in the dataset.