Regulatory status

Status at a glance

503A compounding status

Not nominated

We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.

Status recorded · FDA source document

FDA approval
An FDA-approved product contains this peptide
503B outsourcing
Not determined
Anti-doping (WADA)
Not on the WADA Prohibited List
DEA schedule
Not a controlled substance

About peptide status

Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.

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Status as of

Key takeaway

Human chorionic gonadotropin (hCG; FDA-approved injectable brands include Pregnyl and Novarel) is a placental hormone that acts like luteinizing hormone, triggering ovulation in women and testosterone production in men. It is used in fertility treatment, in male hypogonadotropic hypogonadism, and for undescended testicles in boys, and it is not approved for weight loss. In a Cochrane review of seven trials with 1,136 women, recombinant and urinary hCG gave similar ongoing pregnancy or live-birth rates (odds ratio 1.15, 95% confidence interval 0.89 to 1.49).

At a glance

What it is
A gonadotropin hormone that mimics luteinizing hormone at its receptor
Approved for
Ovulation induction in infertility, male hypogonadotropic hypogonadism, and prepubertal undescended testicles
Key fact
In assisted reproduction, urinary and recombinant hCG trigger final egg maturation with similar pregnancy outcomes
Route
Intramuscular (some products subcutaneous) injection
Evidence strength
FDA approved

Summary

hCG is an FDA-approved hormone that mimics luteinizing hormone. Learn its approved uses, how it works, its risks, and why it is not approved for weight loss.

What is human chorionic gonadotropin?

Human chorionic gonadotropin, abbreviated hCG, is a glycoprotein hormone normally produced by the placenta in pregnancy. The FDA-approved injectable products, such as Pregnyl and Novarel, are purified from the urine of pregnant women; a separate recombinant version, choriogonadotropin alfa (Ovidrel), is made in the laboratory. hCG shares its structure and action closely with luteinizing hormone, one of the pituitary hormones that controls the ovaries and testes.

How does human chorionic gonadotropin work?

hCG binds the same receptor as luteinizing hormone (the LH/CG receptor) and mimics the natural mid-cycle luteinizing hormone surge. In women undergoing fertility treatment, a dose of hCG triggers the final maturation and release of the egg after the follicles have been grown with other hormones. In men, hCG stimulates the Leydig cells of the testes to produce testosterone and supports sperm production, which is why it is used in hypogonadotropic hypogonadism. In boys with non-anatomical undescended testicles, the testosterone it stimulates can promote testicular descent.

In a Cochrane review, urinary-derived and recombinant hCG gave similar ongoing pregnancy or live-birth rates for triggering final egg maturation (odds ratio 1.15, 95% CI 0.89 to 1.49; seven trials, 1,136 women). The FDA has specifically stated that hCG has not been shown to be effective for weight loss and is not approved for that use, despite its promotion in some commercial diet programs.

Is it FDA-approved?

Editor’s note

Status: Yes, for its hormonal indications. The injectable hCG products have been FDA-approved for decades for ovulation induction, male hypogonadism, and cryptorchidism. The agency has separately warned that over-the-counter "homeopathic" hCG weight-loss products are not approved and that prescription hCG is not approved for weight loss.

Category: FDA-approved · Primary body area: Sexual & reproductive

Yes, for its hormonal indications. The injectable hCG products have been FDA-approved for decades for ovulation induction, male hypogonadism, and cryptorchidism. The agency has separately warned that over-the-counter "homeopathic" hCG weight-loss products are not approved and that prescription hCG is not approved for weight loss.

What is human chorionic gonadotropin prescribed for?

In women, hCG is prescribed to induce ovulation and pregnancy in carefully selected cases of infertility, after the follicles have been developed with follicle-stimulating hormone or menotropins. In men, it is used for hypogonadotropic hypogonadism, and in prepubertal boys for undescended testicles not caused by an anatomical blockage.

Evidence in men comes from small or short studies, summarized below:

Study findings for Human chorionic gonadotropin
Study Participants Finding
2021 systematic review pooling 5 hCG trials196 menMean total testosterone rose from 284.5 to 565.6 ng/dL
2018 randomized trial of clomiphene, hCG, or both282 men with hypogonadism who wanted to preserve fertilityTestosterone rose in all 3 arms

What are the side effects?

According to the prescribing information, common side effects include:

  • Injection-site pain
  • Headache
  • Fluid retention or edema
  • Breast tenderness or gynecomastia (in males)
  • Irritability, restlessness, and depression

More serious considerations include:

  • Ovarian hyperstimulation syndrome and multiple pregnancy in fertility use
  • Signs of early puberty in boys treated for cryptorchidism
  • Rare arterial thromboembolism

Sources: FDA prescribing information for Pregnyl and Novarel and FDA statements on hCG weight-loss products; a Cochrane review of recombinant versus urinary hCG for triggering egg maturation (Youssef et al., 2016, DOI: 10.1002/14651858.CD003719.pub4), indexed on PubMed. This document is educational and does not constitute medical advice.

Registered human trials

2 registered human trials on ClinicalTrials.gov that we reviewed

Sources

  1. [1]
  2. [2]

    not been shown

    Primary U.S. Food and Drug Administration

  3. [3]

    FDA-approved (PDF)

    Primary organon.com

  4. [4]

    2021 systematic review

    Primary PubMed

  5. [5]

    2018 randomized trial

    Primary PubMed

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