BLASUBCUTANEOUSINJECTABLE
Approved
May 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
GONAL-F RFF REDI-JECT (follitropin) by Merck & Co. is (fsh), the active component in gonal-f rff redi-ject , is required for normal follicular growth, follicular maturation, and gonadal steroid production. First approved in 2004.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GONAL-F RFF REDI-JECT is a recombinant human follicle-stimulating hormone (FSH) administered subcutaneously to stimulate ovarian follicular growth in women undergoing assisted reproductive technology. The drug works by binding to FSH receptors on ovarian granulosa cells, promoting follicular development, maturation, and gonadal steroid production. It is typically combined with hCG to trigger final follicle maturation and ovulation.
LOE Approaching
As LOE approaches, the commercial team is likely focused on retention and lifecycle management rather than growth initiatives; team size may stabilize or contract post-LOE.
Mechanism of Action
(FSH), the active component in GONAL-f RFF Redi-ject , is required for normal follicular growth, follicular maturation, and gonadal steroid production. The level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching…
Pharmacologic Class:
Gonadotropin
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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)
Started Feb 2026
266 enrolled
Infertility
Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
Started Dec 2025
80 enrolled
InfertilityInsemination
A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants
Started Jul 2025
55 enrolled
Hypogonadism
An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation.
Started Jul 2024
106 enrolled
Infertility
An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation
Started Jun 2024
310 enrolled
Fertility
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.