Follitropin Delta

Summary

Follitropin Delta (CHEMBL5315064) is an approved protein; indicated across 3 conditions including anovulation and infertility disorder.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• Indications: 3 conditions
• Clinical trials: 23

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL5315064
Name	Follitropin Delta
Type	Protein
Max phase	4

Also known as: FE 999049, FE-999049, FE-999049 (R-HFSH), FE-999049 (RECOMBINANT FSH), Follitropin delta, Rekovelle, FOLLITROPIN DELTA

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

3 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
anovulation	4	MONDO:0002775	MONDO:0002775
infertility disorder	3	MONDO:0005047	EFO:0000545

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 23.

Phase distribution

Phase	Trials
Not specified	8
PHASE3	6
PHASE2	6
PHASE1	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03228680	PHASE3	COMPLETED	Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women
NCT03296527	PHASE3	COMPLETED	Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women
NCT03738618	PHASE3	COMPLETED	Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)
NCT03740737	PHASE3	COMPLETED	Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-1)
NCT03809429	PHASE3	COMPLETED	Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
NCT06173869	PHASE3	COMPLETED	A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China
NCT01426386	PHASE2	COMPLETED	A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
NCT02309671	PHASE2	COMPLETED	A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment
NCT03564509	PHASE2	COMPLETED	A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.
NCT03830723	PHASE2	COMPLETED	Personalized Insemination Treatment Study
NCT04778358	PHASE2	COMPLETED	Higher Dose of Rekovelle in Oocyte Donors
NCT05403476	PHASE2	TERMINATED	A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)
NCT04150861	PHASE1	COMPLETED	Rekovelle PK Trial in Chinese Women
NCT06466486	PHASE1	TERMINATED	An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation
NCT06511791	PHASE1	TERMINATED	An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation.
NCT05173597	Not specified	RECRUITING	Real-world Evidence on Follitropin Delta Individual Dosing
NCT06561958	Not specified	ACTIVE_NOT_RECRUITING	Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings
NCT03393780	Not specified	COMPLETED	Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures
NCT03483545	Not specified	COMPLETED	Menopur And Rekovelle Combination Study
NCT03697031	Not specified	TERMINATED	Impact of Blastocyst Morphological Development and Blastocoele Re-expansion on Pregnancy Outcome After Using REKOVELLE®
NCT04503707	Not specified	COMPLETED	Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
NCT05103228	Not specified	COMPLETED	Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders
NCT05873725	Not specified	COMPLETED	Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).