Follitropin Alfa

Summary

Follitropin Alfa (CHEMBL1201692) is an approved protein (ATC G03GA05); indicated across 6 conditions including anovulation and female infertility.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: G03GA05
• Indications: 6 conditions
• Clinical trials: 35

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1201692
Name	Follitropin Alfa
Type	Protein
Max phase	4
ATC	G03GA05

Also known as: Bemfola, Folitropina alfa, Follitropin .alpha., Follitropin alfa, Follitropin alfa component of pergoveris, Follitropin alpha, Follitropine alfa, Gonal f, Gonal-f, Gonal-f rff, Gonal-f rff redi-ject, Human fsh

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

6 indications (4 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
female infertility	4	MONDO:0021124	EFO:0008560
hypogonadism	4	MONDO:0002146	HP:0000044
infertility disorder	3	MONDO:0005047	EFO:0000545
male infertility	2	MONDO:0005372	EFO:0004248

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

Clinical trials

Total trials: 35.

Phase distribution

Phase	Trials
PHASE4	10
PHASE3	8
PHASE1	6
Not specified	6
PHASE2	4
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00249834	PHASE4	COMPLETED	Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)
NCT00257556	PHASE4	COMPLETED	A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa
NCT00334425	PHASE4	UNKNOWN	The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.
NCT00439829	PHASE4	COMPLETED	Synchronization of Follicle Wave Emergence and Ovarian Stimulation
NCT02140515	PHASE4	UNKNOWN	Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation in Patients With Hypogonadotropic Hypogonadism
NCT03057574	PHASE4	UNKNOWN	Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI
NCT03177538	PHASE4	COMPLETED	Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders
NCT04997525	PHASE4	COMPLETED	Estradiol and Progesterone Levels Following Frozen Embryo Transfer
NCT05405686	PHASE4	WITHDRAWN	Effect of LH Supplementation on the Endometrial Gene Expression Profile in Poor Ovarian Responders
NCT05815719	PHASE4	COMPLETED	Continuous Double Ovarian Stimulation.
NCT07340827	PHASE3	RECRUITING	A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
NCT00378001	PHASE3	COMPLETED	Clinical Efficacy and Tolerability of Two FSH Preparations (Human FSH Versus rFSH - Follitropin Alpha) in Women Undergoing IVF
NCT01121666	PHASE3	COMPLETED	Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
NCT01653743	PHASE3	COMPLETED	Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women
NCT02335879	PHASE3	COMPLETED	Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation
NCT02349945	PHASE2/PHASE3	COMPLETED	FSH Receptor Polymorphism p.N680S and Efficacy of FSH Therapy
NCT03296527	PHASE3	COMPLETED	Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women
NCT06091436	PHASE3	COMPLETED	To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
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
NCT00505752	PHASE2	COMPLETED	Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)
NCT00553514	PHASE2	TERMINATED	AS900672-Enriched in Ovulation Induction
NCT01337531	PHASE2	UNKNOWN	Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)
NCT01794208	PHASE2	COMPLETED	Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®
NCT01141270	PHASE1	COMPLETED	Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application
NCT01354886	PHASE1	COMPLETED	Single Dose FSH-GEX™ in Healthy Volunteers
NCT01604044	PHASE1	COMPLETED	Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.
NCT04899193	PHASE1	COMPLETED	Pergoveris FD and Liquid China BE Study
NCT06778304	PHASE1	COMPLETED	Bioequivalence Clinical Trial of Recombinant Human Follicle-stimulating Hormone JZB30
NCT07269327	PHASE1	COMPLETED	An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin
NCT06481696	Not specified	RECRUITING	Possible Action of Resveratrol in Improving the Outcomes of IVF/ICSI in Couples With Unexplained Infertility
NCT06572930	Not specified	RECRUITING	Serum FSH Monitoring for Identification of an Optimal Range During Ovarian Stimulation
NCT03098199	Not specified	COMPLETED	AMH and Dosing Regimens for Initial IVF Stimulation Protocols
NCT03737253	Not specified	COMPLETED	Hormone Evaluation in Artificial Reproductive Technology
NCT04854707	Not specified	COMPLETED	An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
NCT05103228	Not specified	COMPLETED	Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders

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).