PT-141 Research

What PT-141 is

PT-141 is bremelanotide, a synthetic cyclic heptapeptide lactam and an analogue of alpha-melanocyte-stimulating hormone. PubChem resolves CAS 189691-06-3 to CID 9941379, formula C50H68N14O10, molecular weight 1025.2 ^[15]. That record is the free base ^[15].

The approved bremelanotide product does not contain the free base. Drugs@FDA lists the active ingredient of VYLEESI as bremelanotide acetate ^[14]. The acetate is a separate PubChem record, CID 91971505, CAS 1607799-13-2, formula C52H72N14O12, molecular weight 1085.2 ^[15]. CAS 189691-06-3 is therefore correct for a free-base research powder. It is not the CAS of the substance inside the approved autoinjector.

PT-141 and melanotan II are not interchangeable

PubChem lists melanotan II separately, as CID 92432, CAS 121062-08-6, formula C50H69N15O9 ^[15]. Its systematic name ends in carboxamide where bremelanotide's ends in carboxylic acid, so bremelanotide is the deamidated form ^[15]. Their regulatory positions run in opposite directions. A field-qualified query of FDA's Drugs@FDA data returns no match for melanotan II as a substance name, so it holds no US approval ^[23]. Melanotan II is named on FDA's list of bulk drug substances that may present significant safety risks ^[19]. FDA's rationale there cites published case reports of melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism ^[19]. Neither "bremelanotide" nor "PT-141" appears anywhere on that list ^[19]. Neither compound's status transfers to the other.

The approved product and its stated limits

Bremelanotide holds a current US approval. Drugs@FDA records NDA 210557, sponsor Cosette, with the original application approved on 21 June 2019 and a supplement approved on 23 October 2020 ^[14]. The product is VYLEESI, a subcutaneous autoinjector carrying prescription marketing status ^[14]. Its FDA label has an effective date of 13 November 2025, so this is a current record rather than a legacy one ^[2].

The indication is narrow, and the label states it exactly. VYLEESI is indicated for premenopausal women with acquired, generalized hypoactive sexual desire disorder, or HSDD ^[2]. The label defines that as low sexual desire causing marked distress or interpersonal difficulty ^[2]. The same sentence excludes desire problems due to a co-existing medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug substance ^[2]. Those three exclusions are part of the indication, not commentary on it.

The label then limits its own use, in its own words: "VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men. VYLEESI is not indicated to enhance sexual performance." ^[2]

The approved product is a metered, single-dose prefilled autoinjector of bremelanotide acetate, dispensed on prescription after a clinical diagnosis ^[2][14]. Its label does not recommend more than eight doses in a month ^[2]. It is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease ^[2]. The label also directs that the medicine be discontinued after 8 weeks if the patient reports no improvement in her symptoms ^[2]. None of those conditions attach to a vial of research powder.

In the European Union and Canada the position differs. The European Medicines Agency publishes no assessment report for Vyleesi, and Health Canada's drug product database returns no record for the brand or the ingredient ^[21]. That is an absence of authorization. It is not a refusal and not a withdrawal, and no record of either was found ^[21].

Mechanism of action

(human, regulatory) The label describes bremelanotide as a [melanocortin receptor](/glossary#term-melanocortin-receptor) agonist that nonselectively activates several subtypes, in the potency order MC1R, MC4R, MC3R, MC5R, MC2R ^[2]. It states that binding at MC1R and MC4R is the most relevant at therapeutic dose levels ^[2]. It also states plainly that "The mechanism by which VYLEESI improves HSDD in women is unknown." ^[2] The regulator asserts no established causal pathway for the effect in HSDD.

The pigmentation part of the mechanism is understood. The label records that MC1R is expressed on melanocytes, and that binding there leads to melanin expression and increased pigmentation ^[2].

What the pivotal human trials found

(human) RECONNECT was two identical randomized, double-blind, placebo-controlled Phase 3 trials, NCT02333071 and NCT02338960 ^[1]. Of 1,267 women randomized, 1,247 formed the safety population and 1,202 the modified intention-to-treat population ^[1]. Participants were 85.6% white and 96.6% from US sites, with a mean age of 39 ^[1]. The RECONNECT publication labels the pair study 301 and study 302, and the FDA label for VYLEESI calls the same two trials study 1 and study 2 ^[1][2].

(human) Both RECONNECT co-primary endpoints reached statistical significance. The placebo-subtracted increase in the FSFI desire domain was 0.30 in study 301 and 0.42 in study 302, integrated 0.35, all P<.001 ^[1]. The placebo-subtracted reduction in FSDS-DAO item 13 was -0.37 and -0.29, integrated -0.33 ^[1].

Those figures only mean something on their scales. The FSFI desire domain runs from 1.2 to 6.0, and the trials' own responder threshold was an increase of at least 1.2 points ^[2]. FSDS-DAO item 13 runs from 0 to 4, and its responder threshold was a decrease of at least 1 point ^[2]. The average effect was therefore roughly a quarter to a third of the change the trialists themselves defined as meaningful.

(human) The endpoint closest to lived experience did not move. The label states there was no significant difference between groups in the change in the number of satisfying sexual events, a secondary endpoint ^[2]. Mean change was 0.0 against -0.1 in study 1, and 0.0 against 0.0 in study 2, with p values of 0.76 and 0.70 ^[2]. Median change was zero in all four arms ^[2].

(human) Dropout was heavily asymmetric. More patients on drug than on placebo failed to complete the 24-week double-blind period, at 40% against 13% in study 1 and 39% against 25% in study 2 ^[2]. The label states that an exploratory analysis of patients who completed the treatment period was performed because of that imbalance ^[2]. An efficacy estimate is fragile when roughly four in ten assigned participants never reach the endpoint.

(human) The size of the desire and distress effects is hard to judge without a comparison from other trials in this field. A meta-analysis of eight placebo-controlled trials in female sexual dysfunction found placebo arms improved by 3.62 points on the total FSFI, against 5.35 points in treatment arms ^[13]. Its authors concluded that 67.7% of the treatment effect was accounted for by placebo ^[13].

The independent re-analysis, and the dispute it started

(human) An independent academic re-analyzed both trials using the FDA New Drug Application as his source ^[3]. He reported that 72.72% of protocol-listed outcomes were not reported by the trial publication, which instead gave 15 secondary measures absent from the protocols ^[3]. His meta-analysis reproduced results similar to the published ones ^[3]. He also reported two findings the publication did not. Adverse-event-induced discontinuation on drug against placebo carried an odds ratio of 11.98 (95% CI 3.74 to 38.37, NNH 6) ^[3]. A composite of completing the trial and electing to enter the open-label extension favored placebo, at an odds ratio of 0.30 (95% CI 0.24 to 0.38, NNH 4) ^[3]. His stated conclusion is that the drug "is generally not useful" ^[3].

(human) A follow-up paper recovered the unpublished endpoints. Eight of the 11 efficacy outcomes specified on ClinicalTrials.gov had gone unpublished, including FSDS-DAO total score, FSFI total score and the FSFI arousal domain ^[4]. When the authors analyzed them, "effect sizes ranged from nil to small" ^[4]. The same paper reports that the FSFI, its desire domain, the FSDS-DAO and its item 13 have "questionable, at best, validity evidence for women with HSDD" ^[4]. It found no validity evidence for the categorical responder outcomes published from RECONNECT ^[4].

There is a circularity behind that last point. (human) The responder thresholds used in RECONNECT were derived in the sponsor's own Phase 2b program ^[7]. That paper's own limitations section records that the thresholds came from data in the same clinical trial and from a single-blind phase ^[7]. It also records that several of its analysis types were post hoc ^[7]. Three of its seven authors were Palatin Technologies employees ^[7].

The trial group published a rebuttal, and the dispute is unresolved ^[5]. Its author list is substantially the RECONNECT group and includes two Palatin Technologies employees ^[5]. That asymmetry is part of the record rather than a detail. Both pivotal publications carry the funding statement "Palatin Technologies, Inc., and AMAG Pharmaceuticals, Inc." and name employees of both companies as authors ^[1][6]. The critical work came from an academic psychology department ^[3][4]. No industry funding is disclosed for either paper ^[3][4]. No independent replication of the pivotal trials exists.

(human) An independent 2026 systematic review of 36 studies assessed both drug and non-drug treatments for female sexual dysfunction ^[12]. In its pooled analysis, bremelanotide improved total FSFI and its desire and arousal subscales ^[12]. It also found that mindfulness-based cognitive behavioral therapy improved total FSFI and the desire, arousal and orgasm subscales ^[12]. It records that no study has directly compared cognitive behavioral therapy with pharmacotherapy ^[12].

Long-term data are uncontrolled

(human) A 52-week open-label extension followed the core phase, and all its analyses were descriptive by design ^[6]. Of 856 eligible patients, 684 enrolled and 272 completed ^[6]. That is roughly 60% attrition among people already selected for having tolerated 24 weeks. The larger score changes reported there, 1.25 to 1.30 on the FSFI desire domain, come from an uncontrolled study in a survivor population ^[6]. They are not comparable with the placebo-controlled 0.35 ^[1][6].

Tolerability is the dominant finding

(human) Nausea occurred in 40.0% of treated patients against 1.3% on placebo ^[2]. Thirteen percent of treated patients required anti-emetic medication ^[2]. Eight percent discontinued the trials prematurely because of nausea, and no placebo patient did ^[2]. A randomized Phase 4 study in 228 healthy women tested oral ondansetron given before the drug ^[2]. The registry record for that ondansetron study describes its 228 participants as premenopausal women aged 18 to 55 ^[25]. AMAG Pharmaceuticals, then the North American licensee for VYLEESI, sponsored that ondansetron study ^[17][25]. The label records no significant difference in nausea incidence between the groups ^[2]. It concludes that pre-treatment with oral ondansetron "does not reduce the incidence of VYLEESI-associated nausea and is not recommended." ^[2]

(human) Overall discontinuation due to adverse reactions was 18% on drug against 2% on placebo ^[2]. Flushing occurred in 20.3% against 0.3%, headache in 11.3% against 1.9%, and vomiting in 4.8% against 0.2% ^[2]. Serious adverse reactions were much less common, at 1.1% against 0.5% ^[2]. A low serious-event rate and a heavy tolerability burden are both true of this record.

(human) Focal hyperpigmentation scaled sharply with how often the drug was given. It was reported in 1% of patients receiving up to eight doses per month, in a trial population whose median was ten injections across the whole 24 weeks ^[2]. No placebo-treated patient reported it ^[2]. The pivotal trials permitted up to twelve doses in a month, and the approved label does not recommend more than eight ^[2]. The label ties that lower ceiling to the risk of focal hyperpigmentation and to the time per month with raised blood pressure ^[2]. In another clinical study, 38% of patients developed focal hyperpigmentation after daily dosing for eight days ^[2]. Among those who continued for eight more consecutive days, a further 14% developed new pigmentary changes ^[2]. It involved the face, gingiva and breasts, and patients with dark skin were more likely to develop it ^[2]. The label states that "Resolution of the focal hyperpigmentation was not confirmed in all patients after discontinuation of VYLEESI." ^[2]

(human) The label records transient blood pressure and heart rate changes after each dose ^[2]. Maximal increases were 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after dosing, with heart rate falling by up to 5 beats per minute ^[2]. Values usually returned to baseline within 12 hours ^[2]. The product is not recommended for patients at high risk for cardiovascular disease ^[2].

(human) One case of acute hepatitis appears in the label. The patient had received 10 doses over one year ^[2]. She presented with serum transaminases above 40 times the upper limit of normal, and total bilirubin 6 times that limit ^[2]. Liver tests returned to normal 4 months after the drug was stopped ^[2]. The label states that "Because another etiology was not identified, the role of VYLEESI could not definitively be excluded." ^[2] It adds that there was no imbalance between treatment groups in transaminase outliers ^[2]. One labeled case is not a signal.

(animal) Reproductive toxicity is on the label. Daily subcutaneous dosing of pregnant dogs during organogenesis produced fetal harm at exposures at or above 16 times the maximum recommended human dose by AUC ^[2]. Developmental effects appeared in mouse offspring at 125 times the maximum recommended human dose by AUC and above ^[2]. The lowest harmful dose was not identified in either species ^[2]. The label requires effective contraception and discontinuation if pregnancy is suspected ^[2].

(human) Two drug interactions are labeled. Bremelanotide may slow gastric emptying and reduce absorption of oral medicines that depend on threshold concentrations ^[2]. It may also significantly decrease systemic exposure to orally administered naltrexone, which the label says to avoid because of the severe consequence of naltrexone treatment failure ^[2].

Men are the population with the weakest evidence

Bremelanotide is not approved for men in the United States. The label's Limitations of Use bar that use explicitly ^[2]. No approval of any kind was found in the European Union or Canada ^[21].

On 30 August 2007, Palatin and King Pharmaceuticals announced that they "have delayed plans for the initiation of Phase 3 clinical trials with bremelanotide" for male erectile dysfunction ^[16]. The release states that FDA "raised serious concerns about the acceptable benefit/risk ratio" for a Phase 3 program in that indication ^[16]. It adds that FDA "questioned the overall efficacy results and the clinical benefit of this product in both the general and diabetic ED populations" ^[16]. FDA also "cited blood pressure increases as its greatest safety concern" ^[16]. The same release records FDA's stated alternative ^[16]. FDA "was amenable to proposals for a different drug development pathway, such as for a second-line therapy in non-responders to currently approved PDE-5 inhibitors" ^[16]. The Phase 1 and Phase 2 work behind that program used an intranasal route, which is not the route later approved ^[9][14].

(human) The largest randomized bremelanotide trial in men is not safely citable. A 2008 trial in 342 men with sildenafil-non-responsive erectile dysfunction carries a formal Expression of Concern, published by its journal in January 2023 ^[10][11]. That action is not isolated. A PubMed query for the same author returns 14 records typed as Expression of Concern and 18 typed as Retracted Publication ^[22].

The male program is not dead, and it is also not evidence. Palatin's annual report for the fiscal year ended 30 June 2025 lists a bremelanotide and PDE5 inhibitor co-formulation for men not adequately responsive to PDE5 inhibitor monotherapy ^[18]. The same filing places that candidate among products in the early stages of development ^[18]. No approval and no published controlled efficacy result follow from a pipeline listing.

Commercial ownership of the product has moved more than once. AMAG Pharmaceuticals licensed North American rights in January 2017 ^[17]. It launched the product nationally in September 2019 ^[24]. It terminated that license in July 2020 ^[17]. AMAG paid Palatin $12 million at closing plus $4.3 million the following March to return the asset ^[17]. That exit came roughly ten months after the launch ^[17][24]. Cosette acquired the product in December 2023 and is the current sponsor of record ^[14][18].

Early human work, and compounding enforcement

(human) The first published proof-of-concept study in women used a single intranasal dose in 18 premenopausal women with sexual arousal disorder ^[8]. More women reported moderate or high sexual desire after the drug than after placebo, at P = 0.0114 ^[8]. Among those who attempted intercourse within 24 hours, significantly more were satisfied with their level of arousal, at P = 0.0256 ^[8]. Genital arousal was a non-significant trend, at P = 0.0833 ^[8]. The objective measure failed, in that vaginal vasocongestion did not change significantly compared with placebo ^[8]. Three of the six authors, including the corresponding author, were Palatin Technologies employees ^[8].

FDA has named bremelanotide in a compounding enforcement action. A 2020 warning letter to a compounding firm names "Bremelanotide (PT-141)" among substances whose compounded products "are not eligible for the exemptions provided by section 503A(a)" ^[20]. The inspection behind that letter ran from 20 August to 24 October 2018 ^[20]. That predates the June 2019 approval, so the letter's stated reasoning reflects the pre-approval position ^[14][20]. The letter shows that FDA has acted on compounded bremelanotide. It does not state the substance's current compounding status.

Conclusion

PT-141 is bremelanotide, and bremelanotide holds a real, current US approval. That approval covers premenopausal women with a diagnosed case of acquired, generalized HSDD, in a prescription subcutaneous autoinjector ^[2][14]. The same label states that the product is not indicated in men, not indicated in postmenopausal women, and not indicated to enhance sexual performance ^[2]. Its measured effect on desire in the pivotal trials was statistically significant ^[1]. That effect was well below the trialists' own threshold for meaningful change ^[1][2]. Its most common adverse reaction was nausea, in 40% of treated patients ^[2]. Research-grade material is not a medicine and is not for human consumption.

Frequently Asked Questions

Is PT-141 approved by FDA? Bremelanotide is approved in the United States as VYLEESI, NDA 210557, a prescription subcutaneous autoinjector ^[14]. The approval covers premenopausal women with acquired, generalized HSDD that is not due to a co-existing condition, relationship problems or another medication ^[2]. The label states that it "is not indicated for the treatment of HSDD in postmenopausal women or in men" and "is not indicated to enhance sexual performance" ^[2].

Is the CAS number on a PT-141 powder the same as the approved drug's? No. CAS 189691-06-3 resolves to bremelanotide free base, CID 9941379 ^[15]. The approved product contains bremelanotide acetate, CAS 1607799-13-2, CID 91971505 ^[14][15]. The free-base CAS is correct for a research powder, and it is not the identifier of the substance in the autoinjector.

Is PT-141 the same as melanotan II? No. PubChem lists them as separate records, and bremelanotide is the deamidated form ^[15]. Their regulatory positions run in opposite directions. Melanotan II has no US approval and is named on FDA's list of bulk substances that may present significant safety risks, and neither "bremelanotide" nor "PT-141" appears on that list ^[19][23].

Has the pivotal trial result been independently replicated? No independent replication of the pivotal trials exists. Both were funded by Palatin Technologies and AMAG Pharmaceuticals, and both name employees of those companies as authors ^[1][6]. An independent re-analysis using the FDA New Drug Application reproduced similar results, and reported unpublished outcomes on which "effect sizes ranged from nil to small" ^[3][4]. The trial group published a rebuttal, and the dispute is unresolved ^[5].

References

1. 1

   Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Obstetrics and Gynecology, 2019;134(5):899-908. PMID 31599840.; DOI: 10.1097/AOG.0000000000003500.
2. 2

   US Food and Drug Administration. VYLEESI (bremelanotide) prescribing information, NDA 210557, manufacturer Cosette Pharmaceuticals, Inc. SPL set_id f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf, effective_time 20251113. Retrieved in full via api.fda.gov/drug/label.json, field-qualified on openfda.generic_name:"bremelanotide", 28 August 2026; exactly one record returned.
3. 3

   Spielmans GI. Journal of Sex Research, 2021;58(9):1085-1105. PMID 33678061.; DOI: 10.1080/00224499.2021.1885601. Erratum: J Sex Res 2021;58(9):W1-W2.
4. 4

   Spielmans GI, Ellefson EM. Journal of Sex Research, 2024;61(4):540-561. PMID 36809187.; DOI: 10.1080/00224499.2023.2175192.
5. 5

   Kingsberg SA, Clayton AH, Portman D, Krop J, Jordan R, Lucas J, Simon JA. Journal of Sex Research, 2021;58(9):1106-1107. PMID 33835907.; DOI: 10.1080/00224499.2021.1902926.
6. 6

   Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH. Obstetrics and Gynecology, 2019;134(5):909-917. PMID 31599847.; DOI: 10.1097/AOG.0000000000003514.
7. 7

   Althof S, Derogatis LR, Greenberg S, Clayton AH, Jordan R, Lucas J, Spana C. Journal of Sexual Medicine, 2019;16(8):1226-1235. PMID 31277966.; DOI: 10.1016/j.jsxm.2019.05.012.
8. 8

   Diamond LE, Earle DC, Heiman JR, Rosen RC, Perelman MA, Harning R. Journal of Sexual Medicine, 2006;3(4):628-638. PMID 16839319.; DOI: 10.1111/j.1743-6109.2006.00268.x.
9. 9

   Diamond LE, Earle DC, Rosen RC, Willett MS, Molinoff PB. International Journal of Impotence Research, 2004;16(1):51-59. PMID 14963471.; DOI: 10.1038/sj.ijir.3901139.
10. 10

    Safarinejad MR, Hosseini SY. Journal of Urology, 2008;179(3):1066-1071. PMID 18206919.; DOI: 10.1016/j.juro.2007.10.063. Subject to an Expression of Concern; see reference 11.
11. 11

    Expression of Concern: Safarinejad MR, Hosseini SY. Journal of Urology, published 10 January 2023. PMID 36626345.; DOI: 10.1097/JU.0000000000003117. Indexed as "Expression of concern for J Urol. 2008 Mar;179(3):1066-71".
12. 12

    Toledo RG, Winkelman WD, Reyes-Gonzalez D, Bergeron S, Fladger A, Hacker MR, Anand M. Journal of Minimally Invasive Gynecology, 2026;33(1):16-33.e3. PMID 40543759.; DOI: 10.1016/j.jmig.2025.06.004.
13. 13

    Weinberger JM, Houman J, Caron AT, Patel DN, Baskin AS, Ackerman AL, Eilber KS, Anger JT. Obstetrics and Gynecology, 2018;132(2):453-458. PMID 29995725.; DOI: 10.1097/AOG.0000000000002733.
14. 14

    US Food and Drug Administration, Drugs@FDA. Application NDA210557, sponsor COSETTE; submissions ORIG-1 approved 2019-06-21 and SUPPL-2 approved 2020-10-23; product VYLEESI (AUTOINJECTOR), SOLUTION, SUBCUTANEOUS, marketing status Prescription; active ingredient BREMELANOTIDE ACETATE. Retrieved via api.fda.gov/drug/drugsfda.json, field-qualified on openfda.substance_name:"BREMELANOTIDE", 28 August 2026; exactly one record returned.
15. 15

    NCBI PubChem. CID 9941379 (bremelanotide free base, CAS 189691-06-3, C50H68N14O10, MW 1025.2, UNII 6Y24O4F92S); CID 91971505 (bremelanotide acetate, CAS 1607799-13-2, C52H72N14O12, MW 1085.2, UNII PV2WI7495P); CID 92432 (melanotan II, CAS 121062-08-6, C50H69N15O9, MW 1024.2). All three round-tripped by name and by CID via PUG-REST on 28 August 2026, with systematic names retrieved for the amide against acid comparison.
16. 16

    Palatin Technologies, Inc. and King Pharmaceuticals, Inc. Press release, 30 August 2007, "King Pharmaceuticals and Palatin Technologies Delay Immediate Plans for Phase 3 Clinical Program with Bremelanotide for Erectile Dysfunction". SEC EDGAR EX-99, CIK 0000911216. Retrieved and read in full 28 August 2026.
17. 17

    AMAG Pharmaceuticals, Inc. Press release, 27 July 2020, "AMAG Pharmaceuticals Completes Divestment of Women's Health Assets". SEC EDGAR EX-99.1, CIK 0000792977. Retrieved and quoted directly 28 August 2026.
18. 18

    Palatin Technologies, Inc. Form 10-K for the fiscal year ended 30 June 2025, filed 23 September 2025. SEC EDGAR CIK 0000911216, accession 0001654954-25-011030. Retrieved and searched directly 28 August 2026.
19. 19

    US Food and Drug Administration. "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks." Page retrieved 28 August 2026; the strings "bremelanotide", "PT-141" and "PT 141" return zero occurrences, and Melanotan II appears with its stated safety rationale.
20. 20

    US Food and Drug Administration. Warning Letter, Tailor Made Compounding LLC, MARCS-CMS 594743, 1 April 2020. Retrieved and quoted directly 28 August 2026; inspection dated 20 August to 24 October 2018.
21. 21

    European Medicines Agency, medicine page for Vyleesi and withdrawn-application page for Vyleesi, both HTTP 404 on 28 August 2026; Health Canada Drug Product Database API, brandname=vyleesi and ingredientname=bremelanotide, both returning empty arrays on 28 August 2026.
22. 22

    NCBI PubMed, author-level counts retrieved 28 August 2026: "Safarinejad MR[au] AND Expression of Concern[pt]" returns 14 records, and "Safarinejad MR[au] AND Retracted Publication[pt]" returns 18 records.
23. 23

    US Food and Drug Administration, Drugs@FDA. Query api.fda.gov/drug/drugsfda.json field-qualified on openfda.substance_name:"MELANOTAN II" returned NOT_FOUND, "No matches found", on 28 August 2026.
24. 24

    Palatin Technologies, Inc. Form 10-K for the fiscal year ended 30 June 2020, filed 25 September 2020. SEC EDGAR CIK 0000911216, accession 0001654954-20-010471. States "AMAG launched Vyleesi nationally in September 2019 through select specialty pharmacies", and that the termination agreement was effective 24 July 2020. Retrieved and read directly 28 August 2026.
25. 25

    ClinicalTrials.gov, NCT03973047, "Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran". Lead sponsor AMAG Pharmaceuticals, Inc.; enrollment 228 actual; female participants aged 18 to 55 and premenopausal by modified STRAW criteria; status Completed, run 17 June to 20 July 2019. Retrieved via ClinicalTrials.gov API v2, 28 August 2026. The registry types the study as Phase 1; the FDA label describes the same study as a phase 4 study, and the body follows the label.