Discontinued Sexual & Reproductive Health

Lutropin alfa

also known as: Luveris, rLH

EMD Serono's Luveris — the only recombinant human LH ever FDA-approved (2004, accelerated approval). Discontinued from the US market in 2012; approval formally withdrawn in 2016 after EMD Serono notified the FDA it could not complete the required postmarketing pregnancy-outcome trial.

A recombinant human luteinizing hormone produced in CHO cells with amino acid sequence identical to pituitary LH, approved under FDA accelerated-approval regulations in October 2004 as Luveris (EMD Serono) for stimulation of follicular development in infertile hypogonadotropic-hypogonadal women with profound LH deficiency (LH <1.2 IU/L) when used concomitantly with Gonal-f. In April 2012, EMD Serono informed the FDA it was not feasible to complete the post-marketing trial required to verify clinical benefit on time-to-pregnancy; the product was withdrawn from the US market that May, and the NDA was formally withdrawn by the FDA in April 2016. Not available in the United States as of April 2026; the molecule remains available in some other markets.

Mechanism of action

LH/CG receptor (LHCGR) agonism on ovarian theca cells, supporting androgen production that serves as substrate for granulosa-cell aromatization to estradiol during follicle maturation. In LH-deficient hypogonadotropic-hypogonadal women, LH supplementation is required alongside FSH for adequate follicular development and estradiol response.

Primary uses

  • Historical: stimulation of follicular development with concomitant rFSH in hypogonadotropic-hypogonadal women with LH deficiency (US indication, 2004–2012, approval withdrawn 2016)

Typical dosing

75 IU/day daily (subcutaneous)

Historical dose: 75 IU SC daily concomitantly with 75–150 IU Gonal-f SC daily (two separate injections) until follicular development, not to exceed 14 days unless imminent follicular development was evident.

Regulatory status

FDA-approved under accelerated-approval regulations (21 CFR part 314, subpart H) on October 8, 2004, as Luveris (lutropin alfa for injection, EMD Serono/Merck Serono) for stimulation of follicular development — in combination with Gonal-f — in infertile hypogonadotropic-hypogonadal women with profound LH deficiency (LH <1.2 IU/L). US market discontinuation May 2012. EMD Serono requested withdrawal of the NDA under 21 CFR 314.150(d) because the required postmarketing study could not be completed; the FDA formally withdrew approval in April 2016. The clinical benefit of Luveris was never confirmed in a completed postmarketing trial. Remains marketed in some ex-US jurisdictions.

References

  1. [fda-pi] Luveris (lutropin alfa for injection) Prescribing Information. EMD Serono (historical 2004 label).
  2. [other] FDA Federal Register. "EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS." April 12, 2016.

Related peptides

Follitropin alfa

EMD Serono's Gonal-f — the first recombinant human FSH approved by the FDA (1997). Used for ovulation induction, IVF controlled ovarian stimulation, and male hypogonadotropic hypogonadism fertility induction.

Menotropin

Ferring's Menopur (and earlier Repronex, Humegon) — a urinary-derived FSH/LH combination used for ovulation induction and IVF controlled ovarian stimulation, particularly when LH supplementation is clinically desired.

HCG

An FDA-approved fertility and hypogonadism medication commonly discussed in peptide and TRT communities for post-cycle recovery and testicular preservation during testosterone therapy.

Gonadorelin

The native GnRH decapeptide — the hypothalamic signal that drives LH/FSH release and downstream testosterone/estradiol production. Historically FDA-approved (Factrel, Lutrepulse), now widely used in TRT-adjacent fertility protocols as a testicular-preservation alternative to HCG.
Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.