Who makes FOLITIME®?

FOLITIME® is developed by Gema Biotech S.A..

Last reviewed 2026-04-23 · How we verify

FOLITIME®

Gema Biotech S.A. · Phase 3 active Small molecule

FOLITIME® is a folate metabolism modulator designed to enhance cellular folate availability and support DNA synthesis and cell division.

At a glance

Generic name	FOLITIME®
Also known as	Follitropin alfa (r-hFSH)
Sponsor	Gema Biotech S.A.
Modality	Small molecule
Phase	Phase 3

Mechanism of action

The drug appears to work by optimizing folate-dependent metabolic pathways, potentially through modulation of folate transport or metabolism. This mechanism may support rapidly dividing cells and could have applications in conditions characterized by impaired folate metabolism or in enhancing the efficacy of folate-dependent therapies.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

FOLITIME® CI brief — competitive landscape report
FOLITIME® updates RSS · CI watch RSS
Gema Biotech S.A. portfolio CI