Tuesday, September 9, 2025 9/9/2025

IND-enabling studies to develop triptonide into the first nonhormonal male pill

Award Number: R61HD114186
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/15/2025
PERIOD OF PERFORMANCE END DATE: 01/31/2026

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IND-enabling studies to develop triptonide into the first nonhormonal male pill - Project Summary Our twelve years of research has led to the discovery of triptonide (TN) as a promising non- hormonal male contraceptive agent (Nature Communications, 2021, 12:1253). In addition to its excellent potency and proven oral bioavailability, TN does not cause discernable toxic effects in either mice or monkeys at its minimum effective dose. All available data strongly suggest that TN is worth further investment to develop it as a viable non-hormonal male contraceptive drug candidate. Taking advantage of the R61/R33 funding mechanism, we propose to conduct several Investigational New Drug (IND)-enabling studies to collect data required by the FDA for official IND application. Specifically, we will conduct non-GLP toxicity and safety pharmacology studies to identify the maximum tolerated dose (MTD) followed by a six-month repeat dose toxicity study using MTD and minimum effective doses (MED) in male Sprague-Dawley rats in the R61 phase. In addition, deep learning-based pathological and RNA-seq-based transcriptomic analyses will also be performed. The data will not only guide and corroborate the GLP-compliant toxicity and safety pharmacology studies proposed in the R33 phase, but also provide molecular insights for any potential phenotypes observed. In the R33 phase, we will work with Pharmaron Inc. to perform non-GLP toxicity studies in dogs, in vitro secondary pharmacology, and GLP-compliant repeat-dose toxicity and safety pharmacology studies all as part of a package of studies intended to move triptonide into a Phase I clinical trial.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $376,944 )
2025	2025	LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER	1124 W CARSON ST BLDG MRL	TORRANCE	CA	90502	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	2	1/13/2025	NON-COMPETING CONTINUATION	$318,099
2025	2025	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Child Health and Human Development Extramural Research	003	3	9/1/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$341,600
2025	2025	LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER	1124 W CARSON ST BLDG MRL	TORRANCE	CA	90502	LOS ANGELES	USA	Child Health and Human Development Extramural Research	002	2	9/1/2025	NON-COMPETING CONTINUATION	-$318,099
2025	2025	LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER	1124 W CARSON ST BLDG MRL	TORRANCE	CA	90502	LOS ANGELES	USA	Child Health and Human Development Extramural Research	001	2	4/16/2025	NON-COMPETING CONTINUATION	$35,344
														Subtotal = $376,944

Issue Date FY: 2024 ( Subtotal = $403,750 )
2024	2024	LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER	1124 W CARSON ST	TORRANCE	CA	90502	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	1	1/26/2024	NEW	$403,750
														Subtotal = $403,750

Grand Total All Awards = $780,694

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IND-enabling studies to develop triptonide into the first nonhormonal male pill

Award Number: R61HD114186

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/15/2025

PERIOD OF PERFORMANCE END DATE: 01/31/2026

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