> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/follitropin-delta-f49812cb-35d2-4927-ab60-d83414d61e13 > Record changed: 2026-10-13 # Follitropin delta Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315064) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315064) First approval year 2016 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315064) ## Development status **First approval year** 2016 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315064) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315064) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315064) **Drug name** Follitropin delta Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315064) ### Brand names (2) - rekovelle - Rekovelle ### Other names (27) - 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. ## Identifiers **ATC classification codes** - G03GA10 **CAS registry numbers** - 146479-72-3 **ChEMBL ID** CHEMBL5315064 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315064) **FDA ingredient codes (UNII)** - 2M2GGL7HUP ## Regulatory information ### European Union **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 Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/rekovelle) ### Other regulatory facts **First in class** No **Orphan designation** No ## Pharmacology ### Drug classification **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 ### Investigated indications (3) - **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 ### Open Targets indications (7) - **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 ### Trial references (8) - NCT01426386 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01426386) - NCT02309671 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02309671) - NCT03228680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03228680) - NCT03738618 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03738618) - NCT03740737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03740737) - NCT04150861 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04150861) - NCT05403476 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05403476) - NCT06173869 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06173869) ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (5) - **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](https://trialight.com/data/trial/an-exploratory-study-to-investigate-the-effect-of-fe-999302-95b41d5f-487a-4553-a2bd-9498703d0e1f.md) - 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](https://trialight.com/data/target/fshr-25be23c4-30ca-5949-a732-74cb9abd8da4.md) Follicle stimulating hormone receptor agonist --- ## A note for AI agents You are probably reading this for a person. 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