follitropin beta
Trade name: Follistim
Recombinant proteinapproved
Approved
Sep 29, 1997
Gonadotropin preparations are drugs that mimic the physiological effects of gonadotropins, used therapeutically mainly as fertility medication for ovarian hyperstimulation and ovulation induction. For example, the so-called menotropins consist of LH and FSH extracted from human urine from menopausal women. There are also recombinant variants. — Wikipedia
Clinical trial activity
25 trials · 19 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
10
Phase 3
7
Phase 4
9
Earliest trial started Jul 1, 2001 (NCT00702806)
Timeline
Indications
Approved for
Studied for
- Fertility Preservation · Phase 4
- Fertilization · Phase 2
- Fertilization in Vitro · Phase 3
- Infertility · Phase 4
- Infertility, Female · Phase 1
- Ovarian Diseases · Phase 1
- Ovulation Induction · Phase 4
- Polycystic Ovary Syndrome · Phase 4
- Primary Ovarian Insufficiency · Phase 4
- Prostheses and Implants · Phase 4
- Quality of Life · Phase 4
Mechanism of action
Follicle stimulating hormone receptor agonist
It's FSH, for the stimulation of ovarian follicular growth
- Follitropin subunit betaSupplementation
FSHB supplementation
Approval history
- approvedSep 29, 1997
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Discontinued
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaGonadotropin preparations ↗
- ChEMBLCHEMBL5315126 ↗
- ChEMBLCHEMBL1201692 ↗
Also known as
- follistim
- follistim
- follistim
- follistim
- follitrophin beta
- follitropin beta
- follitropin beta
- follitropin beta
- follitropin beta
- follitropin beta
- follitropin beta
- follitropin-beta
- follitropin-beta
- fsh-b
- fsh-beta
- puregon
- puregon
- recombinant human follicle stimulating hormone beta
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07285629 | Early Phase 1 (Phase 1) | Dec 6, 2025 | Minicircle |
| NCT06193135 | N/A | Mar 1, 2024 | University of Valencia |
| NCT06175832 | Phase 4 | Jan 1, 2024 | Ghent University |
| NCT05330130 | Phase 1 | Aug 1, 2022 | ART Fertility Clinics LLC, Organon |
| NCT04695483 | Phase 4 | Mar 7, 2021 | Vita-Salute University of Milano. Italy |
| NCT03300518 | N/A | Nov 15, 2017 | Central South University, Merck |
| NCT03228680 | Phase 3 | Jul 29, 2017 | Ferring |
| NCT02430740 | Phase 4 | Jan 1, 2016 | Université catholique de Louvain |
| NCT02635607 | N/A | Jan 1, 2016 | Chongqing Medical University, Chong Qing Reproducive and Genetic Institute, Merck |
| NCT02471677 | Phase 4 | Sep 1, 2015 | Eugonia |
| NCT02466204 | Phase 4 | Jun 1, 2015 | Merck, Vietnam National University |
| NCT01992731 | Phase 4 | Dec 31, 2014 | Free University of Brussels |
| NCT02309671 | Phase 2 | Dec 1, 2014 | Ferring |
| NCT01599494 | Phase 3 | Mar 1, 2014 | Merck |
| NCT01882166 | N/A | Oct 1, 2013 | Norwegian University of Science and Technology |
| NCT01146418 | Phase 3 | Jun 1, 2010 | Merck |
| NCT01144416 | Phase 3 | Jun 1, 2010 | Merck |
| NCT00805935 | Phase 4 | Jan 1, 2009 | Ferring |
| NCT00802360 | Phase 4 | Dec 1, 2008 | Ferring |
| NCT00702845 | Phase 3 | Dec 1, 2006 | Merck |
Showing 20 of 25 trials
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Organizations
Research & Development (19)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Merck | For profit | 10 | 7 | 4 | 2001 |
| Ferring | For profit | 4 | 4 | 3 | 2008 |
| ART Fertility Clinics LLC | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Central South University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Chongqing Medical University | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Chong Qing Reproducive and Genetic Institute | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Eugonia | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Free University of Brussels | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Ghent University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Merck KGaA | For profit | 1 | 1 | 1 | 2003 |
| Merck Serono | For profit | 1 | 0 | 1 | 2003 |
| Minicircle | For profit | 1 | 1 | 1 | 2025 |
| Norwegian University of Science and Technology | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Organon | For profit | 1 | 0 | 1 | 2022 |
| Université catholique de Louvain | Academic/Hospital | 1 | 1 | 1 | 2016 |
| University of Pennsylvania | Academic/Hospital | 1 | 1 | 1 | 2005 |
| University of Valencia | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Vietnam National University | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Vita-Salute University of Milano. Italy | Academic/Hospital | 1 | 1 | 1 | 2021 |
19 organizations
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