# Phase 2 Kp-10 for Dopamine Agonist Intolerant Hyperprolactinemia IND 74,977

> **NIH FDA R01** · MASSACHUSETTS GENERAL HOSPITAL · 2020 · $337,620

## Abstract

Abstract
Hyperprolactinemia is caused by pituitary tumors and pharmacologic or pathologic interruption of
dopaminergic pathways. Elevated prolactin levels can also cause endocrine dysfunction at multiple levels of
the reproductive cascade including hypogonadotropic hypogonadism, irregular menstruation, erectile
dysfunction, infertility and bone loss. Recent data suggests that hyperprolactinemia causes reduced
kisspeptin expression, which then leads to reductions in GnRH secretion, and hypogonadotropic
hypogonadism. In mice, peripheral kisspeptin administration restores GnRH secretion, gonadotropin release,
and ovarian cycles. In human patients with hyperprolactinemia (Preliminary Data), exogenous kisspeptin
administration also restores gonadotropin secretion. Thus, this application explores the use of exogenous
pulsatile kisspeptin as a therapeutic alternative for patients with hyperprolactemia who are intolerant to
current therapies.

## Key facts

- **NIH application ID:** 9872899
- **Project number:** 5R01FD005712-03
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Stephanie Beth Seminara
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $337,620
- **Award type:** 5
- **Project period:** 2018-04-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9872899

## Citation

> US National Institutes of Health, RePORTER application 9872899, Phase 2 Kp-10 for Dopamine Agonist Intolerant Hyperprolactinemia IND 74,977 (5R01FD005712-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9872899. Licensed CC0.

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