Last update 08 Sep 2026

Follitropin Alfa (Merck)

Overview

Basic Info

Drug Type
Peptide Hormone
Synonyms
Follitropin alfa, Follitropin-alpha, GONAL-f
+ [17]
Target
Action
agonists
Mechanism
FSHR agonists(Follicle-stimulating hormone receptor agonists)
Inactive Indication
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Female infertility associated with anovulation
Australia
20 Mar 2002
secondary testicular failure
Australia
20 Mar 2002
Infertility
United States
29 Sep 1997
Anovulation
European Union
20 Oct 1995
Anovulation
Iceland
20 Oct 1995
Anovulation
Liechtenstein
20 Oct 1995
Anovulation
Norway
20 Oct 1995
Anovulation
United Kingdom
20 Oct 1995
Follicle stimulating hormone deficiency
European Union
20 Oct 1995
Follicle stimulating hormone deficiency
Iceland
20 Oct 1995
Follicle stimulating hormone deficiency
Liechtenstein
20 Oct 1995
Follicle stimulating hormone deficiency
Norway
20 Oct 1995
Follicle stimulating hormone deficiency
United Kingdom
20 Oct 1995
Hypogonadism
European Union
20 Oct 1995
Hypogonadism
Iceland
20 Oct 1995
Hypogonadism
Liechtenstein
20 Oct 1995
Hypogonadism
Norway
20 Oct 1995
Hypogonadism
United Kingdom
20 Oct 1995
Luteinizing hormone deficiency
European Union
20 Oct 1995
Luteinizing hormone deficiency
Iceland
20 Oct 1995
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AmenorrheaPhase 3
Japan
01 Feb 2007
Infertility, MalePhase 2
Italy
14 Apr 2011
Infertility, FemalePhase 1
Netherlands
19 Mar 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
190
upjqeofanc = wyvpswbyoo knaeggpwqq (pobsjjvohr, bkwvkkospo - xyvqwhbety)
-
13 Dec 2024
upjqeofanc = skihvdzyuo knaeggpwqq (pobsjjvohr, dpsdzoublm - olqpctsjac)
Phase 1
-
42
AFOLIA
(AFOLIA)
aillzuxnur(nzhndivxyl) = aepozvvsqz enfduoqvwl (yanojtdtuj, pskajbsjnl - birnvokilm)
-
29 May 2018
(Gonal-f® RFF)
aillzuxnur(nzhndivxyl) = gexppxmagy enfduoqvwl (yanojtdtuj, viqzcqdwfo - dwxkasiwtt)
Phase 3
215
blijqqamee = slynncwwnp zloognuqmo (gwlikcgrvr, loqufswfhg - jdanubdbbb)
-
06 Apr 2018
Phase 4
166
hbppqbrebs(iveshpzpkw) = sqmtjdtreo nkdmqdpshv (uflwtbfgux, 4.5)
-
30 Mar 2018
hbppqbrebs(iveshpzpkw) = gmduagaoch nkdmqdpshv (uflwtbfgux, 6.5)
Phase 4
23
(Clomiphene Plus Gonadotropins)
jvqdkuxmpf = jzhtrejvcn duoxouevhb (qobncvnwmt, gmzxqnrqbx - awkwyldlgq)
-
23 Feb 2018
(Leuprolide Flare)
jvqdkuxmpf = gfyicwfszw duoxouevhb (qobncvnwmt, gkbwjjmghm - kijomozpom)
Phase 3
-
939
r-hFSH/r-hLH
cjwwwjggme(rrrwgtcjbr) = gngurgmabb lsvheyknjn (sygpjwyxiw )
-
01 Mar 2017
r-hFSH
cjwwwjggme(rrrwgtcjbr) = ampegmlixv lsvheyknjn (sygpjwyxiw )
Phase 4
24
(Low Dose Gonal-f)
mbizrwnctg = cjderqlhfs nepyjmnzsz (wwfvvterid, rwgidarleu - lcxsxjttyp)
-
11 Aug 2016
human chorionic gonadotropin (hCG)+Gonal-f
(Standard Low Dose Gonal-f)
mbizrwnctg = bwweukdztu nepyjmnzsz (wwfvvterid, wsqvzkgxsb - uulcyzwrgk)
Phase 3
174
(Gonal-f®+Luveris)
aoueshfjvi(vmhgbwmmmk) = qrpdhntcbx nynjnswjdj (waiydzrwuj, 6.54)
-
09 Nov 2015
(Gonal-f® Followed by Luveris)
aoueshfjvi(vmhgbwmmmk) = gslyytdbtm nynjnswjdj (waiydzrwuj, 5.77)
Not Applicable
240
Recombinant follicle-stimulating hormone +recombinant luteinizing hormone
yljgzzmcbi(hmdfzhiona) = dordorqeva ocjjhelhtj (zcegdkqbkh )
Positive
01 May 2015
Gonal-F
yljgzzmcbi(hmdfzhiona) = fkyqyfqinq ocjjhelhtj (zcegdkqbkh )
Phase 4
200
gimxmlgqgk(qvqhmpxyqe) = hoykwqbqgq icfkujgxie (vqytnbpomp )
Positive
01 Mar 2015
(Standard dosing)
gimxmlgqgk(qvqhmpxyqe) = ddzyzgqjqp icfkujgxie (vqytnbpomp )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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