PT-141 (Bremelanotide): Legal Status, Side Effects and Price

Legal status of PT-141 (bremelanotide)

FDA-approved drug

Bremelanotide is FDA-approved as Vyleesi, only for premenopausal women with acquired, generalized low sexual desire ^[1]. The maker lists a $99 cash price for a 4-dose box for people without insurance coverage ^[3].

FDA status

FDA approved Vyleesi (bremelanotide) on June 21, 2019 ^[2]. It is approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder ^[1]. It is not approved for men, for postmenopausal women or to enhance sexual performance ^[1]. We did not confirm FDA's position on compounded bremelanotide. FDA has sent warning letters to sellers of "research use only" PT-141 ^{[6] [7]}.

Advisory committee

Not applicable. Bremelanotide is an FDA-approved drug ^[2].

FDA-approved products

Vyleesi (bremelanotide) autoinjector, approved June 21, 2019 ^[2].

Sports (WADA)

Bremelanotide is not named on the 2026 list ^[10].

What happens next

Nothing. A doctor can prescribe Vyleesi now for its approved use ^[1].

Checked against FDA sources on Oct 24, 2026. We update this box when FDA acts. Report a change: [email protected].

Vyleesi: the only FDA-approved bremelanotide

PT-141 was the development code for bremelanotide. FDA approved it as Vyleesi on June 21, 2019 ^[2]. It comes as an autoinjector used as needed before sex ^[1]. Its approved use and warnings come from the label ^[1].

Who the Vyleesi label covers

The label's indication is narrow: premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) ^[1]. The label also states three limits ^[1]:

• It is not indicated for HSDD in postmenopausal women.
• It is not indicated for men.
• It is not indicated to enhance sexual performance.

So "PT-141 for men" and "PT-141 for ED" searches are about uses FDA has not approved. The trials behind the approval enrolled only women ^[2].

What the trials showed

FDA's Drug Trials Snapshot describes two 24-week placebo-controlled trials in 1,247 women aged 19 to 56 with acquired, generalized HSDD ^[2]. In both:

• Desire scores (a questionnaire where higher is better) rose about 0.5 to 0.6 points on Vyleesi, compared with about 0.2 points on placebo ^[2].
• Distress about low desire fell about 0.7 points on Vyleesi, compared with about 0.4 on placebo ^[2].

These are averages for groups, not a promise for any one person. Most participants were White, so FDA said differences by race could not be determined ^[2]. The label says to stop Vyleesi after 8 weeks if symptoms have not improved ^[1].

Side effects and warnings on the label

Most common side effects in the Vyleesi trials

Side effect	Vyleesi	Placebo
Nausea	40.0%	1.3%
Flushing	20.3%	0.3%
Injection site reactions	13.2%	8.4%
Headache	11.3%	1.9%
Vomiting	4.8%	0.2%

• Blood pressure and heart rate. Blood pressure rises and heart rate drops briefly after each dose, usually resolving within 12 hours; in studies the largest average rise in systolic pressure was 6 mmHg and heart rate fell by up to 5 beats per minute ^[1].
• Who should not use it. People with uncontrolled high blood pressure or known cardiovascular disease ^[1].
• Skin darkening. Focal hyperpigmentation, including on the face, gums and breasts, was reported by 1% of patients; FDA notes it occurred more often in Black patients than in White patients ^{[1] [2]}.
• Nausea. Reported by 40%, and 13% needed anti-nausea medicine ^[1].
• Naltrexone. Avoid using it with oral naltrexone products taken for alcohol or opioid addiction ^[1].

How to get PT-141 legally, and what it costs

The legal route is a prescription for Vyleesi, filled by a pharmacy. The maker's program lists these prices, checked Oct 24, 2026:

Vyleesi (bremelanotide) prices as published

Channel	Price as published	Conditions	Checked	Source
Maker program, no insurance coverage	$99 per 4-dose box	Also offered if coverage is denied; copay help applies to 2 fills every 30 days; must be 18 or older	Oct 24, 2026	[3]
Maker program, commercial insurance	As little as $0 per 4-dose box	Most eligible commercially insured patients, per the maker	Oct 24, 2026	[3]
Pharmacy retail (SingleCare listing)	$1,428.26 typical price for 4 pens; $983.62 with SingleCare	Drug only; the listing is inconsistent on 1 vs 4 pens	Oct 19, 2026	[4]

Insurance: Cigna's coverage policy recommends prior authorization and covers it for premenopausal women with HSDD, not for men or postmenopausal women ^[5]. Check your own plan's rules before filling.

Compare other legal peptide prices on our legal peptide price tracker.

Compounded and research PT-141

Telehealth companies also sell compounded PT-141 in injection, nasal spray or troche form. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality. We could not confirm FDA's position on compounding bremelanotide, so we do not list those offers here as a legal route; their prices and our notes on legal status are on the price tracker.

Vials sold as "research use only" are a different matter. On Aug 24, 2026, FDA sent warning letters to Royal Peptides LLC and Peptide Partners LLC for selling unapproved drugs that included PT-141 ^{[6] [7]}. More on our FDA warning letters page.

PT-141 vs Melanotan II

Bremelanotide is often confused with Melanotan II, a tanning peptide. Melanotan II has no FDA approval, cannot be compounded, and FDA cites case reports of melanoma and other serious harms with it ^{[8] [9]}. See our Melanotan 2 page.

PT-141 and sports

Bremelanotide is not named on the 2026 WADA Prohibited List ^[10]. Athletes should still check with their anti-doping agency before using any new drug.

What changed

• Aug 24, 2026: FDA sent warning letters to online sellers of research-use PT-141 and other peptides ^{[6] [7]}.
• Jun 21, 2019: FDA approved Vyleesi (bremelanotide) ^[2].

The other FDA-approved peptide drug with its own page here: SS-31. Unapproved peptides with pending reviews include GHK-Cu, epitalon and TB-500.

How we check

Label facts come from the FDA label and FDA's Drug Trials Snapshot ^{[1] [2]}. We rechecked the maker's price page on Oct 24, 2026 ^[3]. We do not link to research chemical sellers. See our editorial standards, our peptide FDA status tracker and hormone therapy for related care.