Choriogonadotropin alfa
Highest phase reached
Approved
Drug type
Protein
First approval year
2000
- First approval year
- 2000
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Choriogonadotropin alfa
- ovidrel
- Ovidrel
- ovitrelle
- Ovitrelle
- atc code g03 ga gonadotropins
- ATC CODE G03 GA GONADOTROPINS
- choriogonadotropin alfa
- Choriogonadotropin alfa
- CHORIOGONADOTROPIN ALFA [EMA EPAR]
- choriogonadotropin alfa [INN]
- CHORIOGONADOTROPIN ALFA [JAN]
- CHORIOGONADOTROPIN ALFA [MART.]
- CHORIOGONADOTROPIN ALFA [MI]
- CHORIOGONADOTROPIN ALFA [ORANGE BOOK]
- CHORIOGONADOTROPIN ALFA [USAN]
- CHORIOGONADOTROPIN ALFA [VANDF]
- Choriogonadotropin alfa [WHO-DD]
- choriogonadotropin alfa ema epar
- choriogonadotropin alfa inn
- choriogonadotropin alfa jan
- choriogonadotropin alfa mart
- choriogonadotropin alfa mi
- choriogonadotropin alfa orange book
- choriogonadotropin alfa usan
- choriogonadotropin alfa vandf
- choriogonadotropin alfa who dd
- choriogonadotropin alpha
- Choriogonadotropin alpha
- Choriogonadotropin Alpha
And 33 more, listed on the interactive page.
- ATC classification codes
- G03GA08
Sources for recorded values
- CAS registry numbers
- 177073-44-8
- ChEMBL ID
- CHEMBL1201464
- RxNorm IDs (RxCUI)
- 283550
- FDA ingredient codes (UNII)
- 6413W06WR3
- Applicant
- EMD SERONO
- Approval date
- 20 Sept 2000
- Application number
- BLA021149
- Status
- Authorised
- Status date
- 2 Feb 2001
- Authorisation date
- 2 Feb 2001
- Approved indications
- Ovitrelle is indicated in the treatment of: women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth; anovulatory or oligo-ovulatory women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.
- Product number
- EMEA/H/C/000320
- Authorisation holder
- Merck Europe B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Anovulation
- Infertility, Female
- Reproductive Techniques, Assisted
European medicines record
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- United States (FDA)
- Approved
- European Union (EMA)
- Authorised
- Drug name stem
- -pin; -trop-
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Luteinizing hormone/Choriogonadotropin receptor agonist
- Action type
- Agonist
- Target
- Lutropin-choriogonadotropic hormone receptor
- Protein identifier
- P22888
Open Targets mechanisms
- Mechanism
- Luteinizing hormone/Choriogonadotropin receptor agonist
- Action type
- Agonist
- Target
- Lutropin-choriogonadotropic hormone receptor
- Condition
- Reproductive Techniques, Assisted
- Highest recorded phase
- 4
- Subject identifier
- D027724
- Condition
- Infertility
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000545
- Subject identifier
- D007246
- Condition
- Polycystic Ovary Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000660
- Subject identifier
- D011085
- Condition
- Obesity
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Primary Ovarian Insufficiency
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004266
- Subject identifier
- D016649
- Condition
- Infertility, Female
- Highest recorded phase
- 4
- Condition identifier
- EFO:0008560
- Subject identifier
- D007247
- Condition
- Hypogonadism
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0002146
- Subject identifier
- D007006
- Condition
- Anovulation
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0002775
- Subject identifier
- D000858
- Condition
- Ovarian Hyperstimulation Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0011972
- Subject identifier
- D016471
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000545
- Condition identifier
- EFO_0001073
- Condition identifier
- EFO_0002950
- Condition identifier
- EFO_0004266
- Condition identifier
- EFO_0004995
- Highest recorded phase
- 1
- Condition identifier
- EFO_0008560
- Condition identifier
- HP_0000027
- Highest recorded phase
- 3
- Condition identifier
- HP_0000789
- Highest recorded phase
- 4
- Condition identifier
- HP_0005268
- Highest recorded phase
- 3
- Condition identifier
- HP_0008209
- Highest recorded phase
- 1
- Condition identifier
- HP_0011961
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001119
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001572
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001913
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002146
- Condition identifier
- MONDO_0002146
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0002775
- Condition identifier
- MONDO_0002775
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004995
- Condition identifier
- MONDO_0005047
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005133
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005267
- Condition identifier
- MONDO_0005387
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0006823
- Highest recorded phase
- 3
And 9 more, listed on the interactive page.
- Event
- abdominal distension
- Reports
- 82
- Reporting signal score
- 131.997
- Event
- abdominal pain
- Reports
- 95
- Reporting signal score
- 64.9907
- Event
- abdominal pain lower
- Reports
- 31
- Reporting signal score
- 51.7012
- Event
- abortion induced
- Reports
- 13
- Reporting signal score
- 17.0373
- Event
- abortion spontaneous
- Reports
- 55
- Reporting signal score
- 79.2375
- Event
- adnexal torsion
- Reports
- 26
- Reporting signal score
- 146.425
- Event
- anovulatory cycle
- Reports
- 4
- Reporting signal score
- 17.6208
- Event
- arthralgia
- Reports
- 3
- Reporting signal score
- 21.5491
- Event
- ascites
- Reports
- 237
- Reporting signal score
- 812.896
- Event
- benign hydatidiform mole
- Reports
- 4
- Reporting signal score
- 14.0934
- Event
- body temperature fluctuation
- Reports
- 19
- Reporting signal score
- 68.2123
- Event
- caesarean section
- Reports
- 15
- Reporting signal score
- 19.7281
- Event
- cephalo-pelvic disproportion
- Reports
- 4
- Reporting signal score
- 15.9626
- Event
- cyst rupture
- Reports
- 5
- Reporting signal score
- 18.723
- Event
- diarrhoea
- Reports
- 10
- Reporting signal score
- 28.3598
- Event
- diverticulitis
- Reports
- 19
- Reporting signal score
- 20.5111
- Event
- dyspnoea
- Reports
- 100
- Reporting signal score
- 21.4201
- Event
- ectopic pregnancy
- Reports
- 25
- Reporting signal score
- 80.3815
- Event
- effusion
- Reports
- 21
- Reporting signal score
- 82.1842
- Event
- fall
- Reports
- 1
- Reporting signal score
- 25.2636
- Event
- fatigue
- Reports
- 10
- Reporting signal score
- 32.0676
- Event
- feeling hot
- Reports
- 19
- Reporting signal score
- 15.1147
- Event
- haematocrit increased
- Reports
- 14
- Reporting signal score
- 44.501
- Event
- haemoconcentration
- Reports
- 6
- Reporting signal score
- 28.27
- Event
- haemorrhagic ovarian cyst
- Reports
- 9
- Reporting signal score
- 33.883
And 38 more, listed on the interactive page.
- NCT00948805
- NCT02118051
- NCT04643925
- NCT05571111
- NCT03071172
- NCT03440359
- Dose
- 4000 USP units; 500 USP units; 5000 USP units; 2000 USP units; 5000 to 10,000 USP units; 10,000 USP units
- Route
- Intramuscular
- How often
- Three times weekly for 3 weeks; every second day for 4 injections; 15 injections over 6 weeks; three times weekly for 4 to 6 weeks; once after gonadotropins; three times weekly for 3 weeks, then twice weekly for 3 weeks; three times weekly for 6 to 9 months, then three times weekly for 3 months
- Reconstitute with solvent, do not shake
- Refrigerate if stored, discard after 60 days if unused
- Use one vial per patient
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Beta Chain
- Type
- Protein
- Sequence
- SKEPLRPRCRPINATLAVEKEGCPVCITVNTTICAGYCPTMTRVLQGVLPALPQVVCNYRDVRFESIRLPGCPRGVNPVVSYAVALSCQCALCRRSTTDCGGPKDHPLTCDDPRFQDSSSSKAPPPSLPSPSRLPGPSDTPILPQ
- Component
- Alpha Chain
- Type
- Protein
- Sequence
- APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
- 44087-1150
Related records
Trials (57)
- A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age
- A Randomized Controlled Study of Different Trigger Modes of Antagonist Regimen in Patients With Low Ovarian Reserve
- 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)
- A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation
- A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.
- An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029)
- An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation.
- An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation
- An Open Label, Canadian Phase IIIb Study With Ovidrel in Ovulation Induction (OI) and Assisted Reproductive Technique (ART)
- An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients
- Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
- Can Biotin Supplementation be Used to Mask hCG Abuse?
- Clinical Research Study to Learn About the Effect and Safety of Different Doses of FE 999302 When Given as a Single Dose for Final Development of the Eggs After Ovarian Stimulation
- Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET
- Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility
- Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity
- Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome
- Comparison of Triggers in Double Ovarian Stimulation (DuoStim).
- Corpus Luteum Function and Cardiovascular Adaptation in a Natural MOCK Cycle.
- Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles
Approved for (6)
- Anovulation
- Female infertility
- Hypogonadism
- Infertility disorder
- Obesity disorder
- Primary ovarian failure
In development for (11)
- Acute graft versus host disease Phase 1
- Endometriosis Phase 3
- Graft versus host disease Phase 2
- Hypogonadotropic hypogonadism Phase 3
- Ischemic stroke Phase 2
- Klinefelter syndrome Phase 3
- Leiomyoma Phase 1
- Oligospermia Phase 2
- Ovarian hyperstimulation syndrome Phase 3
- Polycystic ovary syndrome Phase 2
- Premature menopause Phase 1
Other linked conditions (2)
Targets (1)
- LHCGR Luteinizing hormone/Choriogonadotropin receptor agonist