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Drug

Follitropin alfa

Approved · EMA
Emerging researchLate-stage development
Also known as FSH-a, GONAL-F, Gonal F, rFSH-alpha+5 more

FSH-a, GONAL-F, Gonal F, rFSH-alpha, Folitropina alfa, Follitrophin alfa, Follitrophin alpha, Follitropin alpha, follitropin alfa, recombinant.

RxNorm386938
1
Research papers
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre 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 Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme in China

Clinical trial2026-02-12Results posted · ClinicalTrials.gov

Randomized, Placebo-controlled, Double-blind, Single-center Trial to Evaluate the Possible Action of Resveratrol in Improving the Outcomes of Controlled Ovarian Stimulation During the IVF/ICSI Cycles in Couples With Unexplained Infertility

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

Continuous Ovarian Stimulation in DUOSTIM Cycles.

Clinical trial2025-05-18Results posted · ClinicalTrials.gov

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Ovarian Response of a Starting Dose of 15 μg Follitropin Delta (REKOVELLE) to a Starting Dose of 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

Clinical trial2025-04-02Results posted · ClinicalTrials.gov

Cumulative Pregnancy Rate With Lower and Higher Dose of Gonadotropin During Controlled Ovarian Hyperstimulation During IVF Among Expected Poor Responders: a Prospective, Randomized Controlled Trial

Clinical trial2024-12-13Results posted · ClinicalTrials.gov

Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle

Clinical trial2024-12-06Completed · ClinicalTrials.gov

Clinical Study on Pharmacogenetics of Gonadotropin Receptors in Relation to Pregnancy and Life Birth Rate as Well as Unwanted Side Effects Such as Ovarian Hyper Stimulation Syndrome During Assisted Reproduction.

Clinical trial2024-10-02Completed · ClinicalTrials.gov

Endometrial Gene Expression Profiles During Ovarian Stimulation With Recombinant FSH With or Without the Addition of Recombinant LH in Genuine Poor Responders

Clinical trial2024-08-01Withdrawn · ClinicalTrials.gov

Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa.

Research2020-07-15Reproductive biomedicine online

Approval: Bemfola (EMA)

Regulatory2014-03-26EMA

Approval: Ovaleap (EMA)

Regulatory2013-09-27EMA

Approval: GONAL-f (EMA)

Regulatory1995-10-20EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Follitropin alfa
Aliases & brands
FSH-aGONAL-FGonal FrFSH-alphaFolitropina alfaFollitrophin alfaFollitrophin alphaFollitropin alphafollitropin alfa, recombinant
RxNorm CUI
386938
Regulatory jurisdictions
ema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1995-10-20
Latest approval
2014-03-26
Authorities
EMA
Total events
3
emaEuropean Medicines Agency· 3 events
2014-03-26Approval
Approval: Bemfola (EMA)
Indication: In adult women: anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate; stimulation of multifollicular… Show full indication

In adult women: anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate; stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT); follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l. In adult men: follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.

Evidence ↗
2013-09-27Approval
Approval: Ovaleap (EMA)
Indication: In adult women Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate; Stimulation of multifollicular… Show full indication

In adult women Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate; Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer; Ovaleap in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L. In adult men Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.

Evidence ↗
1995-10-20Approval
Approval: GONAL-f (EMA)
Indication: Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate. Stimulation of multifollicular development in… Show full indication

Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate. Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in-vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/l. GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

32 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
32
registered trials across all phases
LATEST COMPLETION 2025
26
Late-stage (III+)
29
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 32
Phase 15Phase 21Phase 2 / 31Phase 311Phase 49Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle

CompletedPH IVCopenhagen University Hospital at Herlevn=3052024

Endometrial Gene Expression Profiles During Ovarian Stimulation With Recombinant FSH With or Without the Addition of Recombinant LH in Genuine Poor Responders

WithdrawnPH IVCRG UZ Brussel2024

Continuous Ovarian Stimulation in DUOSTIM Cycles.

CompletedPH IVInstituto Bernabeun=302023

An Interventional Study to Assess the Efficacy and Safety of Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI

Unknown statusPH IVMinaPharm Pharmaceuticalsn=2002018

Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.

CompletedPH IVIBSA Institut Biochimique SAn=7102017

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre 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 Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme in China

CompletedPH IIIFerring Pharmaceuticalsn=3012025

Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle

CompletedPH IVCopenhagen University Hospital at Herlevn=3052024

Clinical Study on Pharmacogenetics of Gonadotropin Receptors in Relation to Pregnancy and Life Birth Rate as Well as Unwanted Side Effects Such as Ovarian Hyper Stimulation Syndrome During Assisted Reproduction.

CompletedN/ALund Universityn=8102024

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Ovarian Response of a Starting Dose of 15 μg Follitropin Delta (REKOVELLE) to a Starting Dose of 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

CompletedPH IIIFerring Pharmaceuticalsn=3022024

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial in India Comparing the Efficacy and Safety of FE 999049 (Follitropin Delta) With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

CompletedPH IIIFerring Pharmaceuticalsn=2202023

Cumulative Pregnancy Rate With Lower and Higher Dose of Gonadotropin During Controlled Ovarian Hyperstimulation During IVF Among Expected Poor Responders: a Prospective, Randomized Controlled Trial

CompletedN/APeter Kovacs MDn=1902023

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Reproductive biomedicine online1
Leading researchers
  • Arce JC1
  • García-Velasco JA1
  • Larsson P1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.