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MR-130A-01

Phase 2

Contraception | Small molecule | Endocrine |Viatris Inc.|Last Updated: Jan 26, 2026

Target and mechanism

ModalitySmall molecule

Also known as MR-130A-01 Transdermal patch, 130A-01 patch, 130A-01 contraceptive patch, containing norelgestromin

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment228

FDA Designations

No designations recorded

Clinical trial landscape

MR-130A-01 · 2 trials · 1 indication

Phase 2 2
NCT07365904Investigating Ovulation Inhibition for Use as a ContraceptiveContraception
RECRUITING60 Analytics
NCT06048536Dose-finding Study of MR-130A-01 Contraceptive Transdermal PatchContraception
COMPLETED168 Analytics
PHASE2RECRUITING
Investigating Ovulation Inhibition for Use as a Contraceptive
ContraceptionUnlock trial analytics
PHASE2COMPLETED
Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch
ContraceptionUnlock trial analytics

Study Endpoints

Primary Endpoints

Ovulation incidence in cycle with regular application, and in cycles with extended period application errors. Ovulation is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.
84 days
Proportion of responder overall (subjects with no ovulation in both treatment cycles)
56 days

A responder is a subject with no ovulation. A responder is a subject with no ovulation. Ovulation during treatment is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.

Proportion of responder in cycle (subjects with no ovulation in one of the treatment cycles)
56 days

A responder is a subject with no ovulation. A responder is a subject with no ovulation. Ovulation during treatment is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.

Secondary Endpoints

Ovulation incidence overall and incidence per treatment cycle.
84 days
HSS determined for each treatment cycle.
84 days
Fulfilment of Landgren criterion in cycles with HSS 5 or 6.
84 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
"regular": regular application without planned application errorsEXPERIMENTAL -
Extended Period 1: regular application with planned application errorsEXPERIMENTAL -
Extended Period 2: regular application with planned application errorsEXPERIMENTAL -
Norelgestromin low dose 2.43mg 28/0 regimen non-ObeseEXPERIMENTAL -
Norelgestromin mid dose 3.64mg 28/0 regimen non-ObeseEXPERIMENTAL -
Norelgestromin high dose 4.86mg 28/0 regimen non-ObeseEXPERIMENTAL -
Norelgestromin high dose 4.86mg 21/7 regimen non-ObeseEXPERIMENTAL -
Norelgestromin mid dose 3.64mg 28/0 regimen ObeseEXPERIMENTAL -
Norelgestromin high dose 4.86mg 28/0 regimen ObeseEXPERIMENTAL -
Norelgestromin high dose 4.86mg 21/7 regimen ObeseEXPERIMENTAL -

Interventions

NameTypeDescription
MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)DRUGMR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)
MR-130A-01 Transdermal patchDRUGMR-130A-01 transdermal patch, containing 2.43 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 1\. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years (inclusive) at screening examination. 2\. BMI ≥18.0 kg/m2 at screening examination. 3. Participants must be in good physical and mental health as determined by vital signs, medical history, and physi...

Countries:Germany
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Frequently asked questions about MR-130A-01

What is 130A-01 patch used for?

130A-01 patch is an investigational contraceptive transdermal patch being developed for contraception. It is a small molecule product in Phase 2 clinical development. The patch is designed for use in women aged 18 years and older, and it is being studied as a method of birth control.

Who makes 130A-01 patch?

130A-01 patch is being developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol VTRS. The company is conducting clinical trials to evaluate the safety and efficacy of this contraceptive patch.

What phase is 130A-01 patch in?

130A-01 patch is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for contraception.

What clinical trials is 130A-01 patch in?

130A-01 patch has one completed Phase 2 clinical trial, identified as NCT06048536, titled 'Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch'. This randomized, controlled study enrolled 168 healthy female participants in Germany, aged 18 years and older.

Is 130A-01 patch the same as MR-130A-01?

Yes, 130A-01 patch is also known as MR-130A-01. The clinical trial NCT06048536 refers to the drug as MR-130A-01, indicating that these names are used interchangeably for the same investigational contraceptive transdermal patch.

How does 130A-01 patch work?

130A-01 patch is a small molecule contraceptive delivered through a transdermal patch. The specific molecular target or mechanism of action has not been disclosed in available information. The patch is designed to provide contraception when applied to the skin.