At a glance
- Follitropin alfa is an FDA-approved drug, marketed as Gonal-f, Follistim (first approval: September 29, 1997).
- PubMed lists 297 publications mentioning it, including 64 randomized controlled trials and 6 animal-only studies.
- ClinicalTrials.gov lists 174 registered studies testing it (17 active).
- FDA's adverse event system (FAERS) holds 2,330 reports mentioning it; 1,912 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| BLA020378 | GONAL-F | Approved, marketed | September 29, 1997 | EMD SERONO |
| BLA020582 | FOLLISTIM | Approved, discontinued | September 29, 1997 | ORGANON USA INC |
| BLA021211 | FOLLISTIM AQ | Approved, marketed | March 23, 2004 | ORGANON USA LLC |
| BLA021765 | GONAL-F, GONAL-F RFF | Approved, marketed | March 25, 2004 | EMD SERONO |
| BLA021684 | GONAL-F RFF REDI-JECT | Approved, marketed | May 25, 2004 | EMD SERONO |
| BLA021273 | FOLLISTIM AQ | Approved, discontinued | August 26, 2005 | ORGANON USA INC |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- The Variability in the Pharmacokinetics of Follitropin Alfa: A Systematic Review.
- Real-world utilization of gonadotropins and the associated cumulative live birth rates in the United States: a retrospective claims database analysis.
- The progestin anchor: salvaging mature oocyte yield after an unplanned six-day gonadotropin pause in oncofertility-a case report.
- Comparative outcomes of conventional follitropin delta 15 µg/day versus follitropin alfa 225 IU/day for ovarian stimulation: results from an exploratory post hoc analysis of Spanish participants from the ADAPT-1 randomized controlled trial.
- Recombinant Human Follicle-Stimulating Hormone Injection versus Gonal-f® in Controlled Ovarian Stimulation for Assisted Reproductive Technology: A Multicenter, Randomized, Assessor-Blind, Active-Controlled Phase III Trial.
- Comparison of a single dose of follitropin alfa administered before or after clomiphene citrate in the treatment of unexplained infertility.
- Corifollitropin alfa versus daily recombinant FSH for ovarian stimulation in women of advanced maternal age: a cost-minimization analysis in an out-of-pocket setting.
- Restoration of spermatogenesis in a male with prolactinoma-induced hypogonadotropic hypogonadism using follitropin delta and recombinant choriogonadotropin alfa: a case report.
- Reverse-Phase High-Performance Liquid Chromatography/Mass Spectrometry (RP-LC-MS/MS, Label-Free Method) for Component Analysis of Gonadotropin Drugs.
- Cost-Effectiveness of Follitropin Delta Compared with Follitropins Alfa and Beta in Controlled Ovarian Stimulation for Assisted Reproductive Technologies (ART) in France.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 174
- Active
- 17
- With posted results
- 46
Conditions studied
Show 40 more studies
All 174 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2,330
- Serious
- 1,912
- With death outcome
- 33
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.