Follitropin delta
Highest phase reached
Approved
Drug type
Protein
First approval year
2016
- First approval year
- 2016
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Follitropin delta
- rekovelle
- Rekovelle
- fe 999049
- FE 999049
- fe 999049 r hfsh
- fe 999049 recombinant fsh
- fe 999049 recombinant human follicle stimulating hormone
- FE-999049
- FE-999049 (R-HFSH)
- FE-999049 (RECOMBINANT FSH)
- FE-999049 (RECOMBINANT HUMAN FOLLICLE-STIMULATING HORMONE)
- follitropin delta
- Follitropin delta
- Follitropin Delta
- Follitropin Delta (FE 999049)
- Follitropin delta (Rekovelle)
- follitropin delta [INN]
- FOLLITROPIN DELTA [JAN]
- FOLLITROPIN DELTA [USAN]
- Follitropin delta [WHO-DD]
- follitropin delta inn
- follitropin delta jan
- follitropin delta usan
- follitropin delta who dd
- recombinant FSH
- Recombinant FSH
- REKOVELLE
And 2 more, listed on the interactive page.
- ATC classification codes
- G03GA10
- CAS registry numbers
- 146479-72-3
- ChEMBL ID
- CHEMBL5315064
- FDA ingredient codes (UNII)
- 2M2GGL7HUP
- Status
- Authorised
- Status date
- 12 Dec 2016
- Authorisation date
- 12 Dec 2016
- Approved indications
- Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
- Product number
- EMEA/H/C/003994
- Authorisation holder
- Ferring Pharmaceuticals A/S
- 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
European medicines record
- First in class
- No
- Orphan designation
- No
- Drug name stem
- -pin; -trop-
Mechanisms of action
- Mechanism
- Follicle stimulating hormone receptor agonist
- Action type
- Agonist
- Target
- Follicle-stimulating hormone receptor
- Protein identifier
- P23945
Open Targets mechanisms
- Mechanism
- Follicle stimulating hormone receptor agonist
- Action type
- Agonist
- Target
- Follicle-stimulating hormone receptor
- Condition
- Reproductive Techniques, Assisted
- Highest recorded phase
- 4
- Subject identifier
- D027724
- Condition
- Infertility
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000545
- Subject identifier
- D007246
- Condition
- Anovulation
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0002775
- Subject identifier
- D000858
- Condition identifier
- EFO_0000545
- Highest recorded phase
- 3
- Condition identifier
- HP_0000789
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002775
- Condition identifier
- MONDO_0002775
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005047
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005133
- Condition identifier
- MONDO_0100234
- Highest recorded phase
- 2
- NCT01426386
- NCT02309671
- NCT03228680
- NCT03738618
- NCT03740737
- NCT04150861
- NCT05403476
- NCT06173869
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Disulfide bridges beta
- Sequence
- C3-C51 $ C17-C66 $ C20-C104 $ C28-C82 $ C32-C84 $ C87-C94
- Component
- Disulfide bridges alpha
- Sequence
- C7-C31 $ C10-C60 $ C28-C82 $ C32-C84 $ C59-C87
- Component
- Sequence: Beta subunit
- Type
- Protein
- Sequence
- NSCELTNITIAIEKEECRFCISINTTWCAGYCYTRDLVYKDPARPKIQKTCTFKELVYETVRVPGCAHHADSLYTYPVATQCHCGKCDSDSTDCTVRGLGPSYCSFGEMKE
- Component
- Alpha Chain
- Type
- Protein
- Sequence
- APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
- Component
- Glycosylation sites (N)
- Sequence
- N52 $ N78 $ N7 $ N24
Related records
Trials (56)
- A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment
- A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
- A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China
- A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)
- A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled 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 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
- Antagonist/Letrozole in Poor Responders
- Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles
- Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial
- Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders
- Dysregulation of FSH in Obesity: Functional and Statistical Analysis
- Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.
- Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes.
- Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology During IVF/ICSI
- Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI
- Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women
- Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women
- Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women
Approved for (1)
- Anovulation
In development for (2)
- Infertility disorder Phase 3
- Paroxysmal familial ventricular fibrillation Phase 2
Targets (1)
- FSHR Follicle stimulating hormone receptor agonist