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MYCAPSSA Delivers the Efficacy of Octreotide

Largest Clinical Trial Dataset for an Oral Acromegaly Therapy

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The safety and efficacy of MYCAPSSA were studied in 3 clinical trials.1-4

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329* people living with acromegaly, who responded to and tolerated injectable somatostatin analog (SSA) treatment with octreotide or lanreotide, participated in the trials.
Study
 Treatments studied Number of participants Outcome
Phase 3
Open-Label Study
 MYCAPSSA N=155
  • Assessed efficacy and safety profiles of MYCAPSSA
OPTIMAL
 MYCAPSSA vs placebo N=56
  • Established efficacy and safety profiles of MYCAPSSA
  • Led to the FDA approval of MYCAPSSA
MPOWERED
 MYCAPSSA vs injectable SSA N=146
  • Demonstrated that MYCAPSSA maintained biochemical control†
Study
Phase 3
Open-Label Study
Treatments studied
MYCAPSSA
Number of participants
N=155
Outcome
  • Assessed efficacy and safety profiles of MYCAPSSA
Study
OPTIMAL
Treatments studied
MYCAPSSA vs placebo
Number of participants
N=56
Outcome
  • Established efficacy and safety profiles of MYCAPSSA
  • Led to the FDA approval of MYCAPSSA
Study
MPOWERED
Treatments studied
MYCAPSSA vs injectable SSA
Number of participants
N=146
Outcome
  • Demonstrated that MYCAPSSA maintained biochemical control†
The MPOWERED study was not powered to report noninferiority or superiority between arms for symptoms and patient-reported outcomes. Patients who enrolled did so with the understanding that they may receive MYCAPSSA. The enrolled population may have been enriched for those who were unsatisfied with injectable therapy.
FDA, US Food and Drug Administration; IGF-I, insulin-like growth factor 1; ULN, upper limit of normal.
*Twenty-eight patients in OPTIMAL received placebo.
†Primary endpoint of noninferiority assessment of the proportion of patients maintaining biochemical response (IGF-I <1.3 × ULN using time-weighted average) throughout the randomized, controlled treatment phase.
MYCAPSSA Delivers the Proven Efficacy of Octreotide
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In the OPTIMAL Trial1:
  • ~60% of patients on MYCAPSSA maintained IGF-I response‡ vs ~20% of patients on placebo
  • Mean IGF-I levels in patients on MYCAPSSA were maintained within the normal range
  • 90% of patients who received MYCAPSSA in the OPTIMAL core study chose to remain on therapy in the open-label extension
Mean Levels of IGF-I at Baseline vs End of Treatment
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In the MPOWERED Trial2:
  • The primary endpoint of noninferiority to iSSA was met
  • 91% of MYCAPSSA-treated patients maintained biochemical control§ vs 100% of those treated with an iSSA
  • Biochemical response was similar among patients previously treated with injectable octreotide and those previously treated with lanreotide5
Biochemical Responders at 15 Months
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In the MPOWERED
Open-Label Extension6:
  • Patients who completed the MPOWERED core trial were invited to participate in the open-label extension phase
  • All participants received MYCAPSSA regardless of their prior randomized controlled treatment assignment
Proportion of Biochemical Responders 
at the End of Each Year6||
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iSSA, injectable somatostatin analog; ULN, upper limit of normal.
95% confidence intervals (CI) represent number of patients.
‡IGF-I response was defined as an average of weeks 34 and 36 IGF-I ≤1.0 × ULN (P = .008); 58% of patients on MYCAPSSA maintained IGF-I response vs 19% of patients on placebo.
§Data are representative of patients responding to both iSSAs and MYCAPSSA. Biochemical response was defined as IGF-I <1.3 x ULN using time-weighted average.
||A patient was considered a responder at the beginning or end of the year if their IGF-I was <1.3 × ULN. Patients who entered a year as a responder and had an end-of-year response were included in the year’s analysis.
“It's nice to know that I am doing well and it's 
nice to know that I'm on a medication that 
keeps me consistent.”

— Bonnie, MYCAPSSA patient

This is Bonnie's experience and may not be representative of every patient taking MYCAPSSA.
Bonnie
Control of Common and Breakthrough Symptoms
Across Multiple Trials, MYCAPSSA-Treated Patients Demonstrated Consistent Symptom Control2,4,7
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Open-Label Trial
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mPoweredTrial
MPOWERED Trial#
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Proportion of patients with active individual symptoms from baseline to end of treatment. Fixed-dose population (n = 110). For patients not completing the core treatment period, the last assessment during the core treatment period was used. For patients not completing the extension treatment period, the last assessment during the extension treatment period was used.
#Proportion of patients with active individual symptoms at indicated timepoint during run-in phase.
Fewer Patients Have Reported Breakthrough Symptoms:
Breakthrough symptoms were defined as any worsening of symptoms prior to the next scheduled dose of medication for the treatment of acromegaly.2,8
mPoweredTrial
In the MPOWERED Trial1:
In patients previously treated with iSSAs, fewer MYCAPSSA-treated patients reported breakthrough symptoms at the end of the run-in phase vs baseline.
Reported Breakthrough Symptoms
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Patients Reported Long-Term Symptom Control6
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Symptom control was evaluated for up to 3.5 years
  • In the MPOWERED core trial, patients were treated with either MYCAPSSA or an iSSA, then transitioned to MYCAPSSA in the open-label extension
  • Clinically validated—patients were evaluated using the validated Acro-TSQ, which delivers scientific rigor to the acromegaly treatment experience**
By the end of the open-label extension, more MYCAPSSA patients reported experiencing “excellent” or “very good” symptom control vs baseline.
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**Participants completed the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ), a validated patient-reported outcome tool used to assess overall treatment satisfaction and convenience, and patient perception of adverse drug reactions and symptomatic control, at months 3, 6, and 12 followed by every 12 months during the open-label extension phase. Acro-TSQ scores were a key exploratory endpoint and the open-label extension phase of MPOWERED was not powered for statistical testing.
“I'm just very thankful and grateful that I have found something that fits my lifestyle.”

— Becky, MYCAPSSA patient

This is Becky's experience and may not be representative of every patient taking MYCAPSSA.
MYCAPSSA Has a Well-Established Safety Profile 
A Safety Profile Consistent With Octreotide, Without Injection-Related Reactions4
  • In clinical studies, MYCAPSSA was shown to be generally well tolerated1,3
  • GI-related adverse events were mostly transient and resolved in less than 2 weeks.4 Across 2 phase 3 trials, GI-related AEs were:
    • Reported in 57% and 68% of patients
    • Mostly mild to moderate and occurred during the initial 3 months of treatment

Most GI-related AEs are temporary. Encourage patients to stay in touch as you work through it together.

AE, adverse event; GI, gastrointestinal.
+35 years
The MYCAPSSA safety profile is supported by more than 3 decades of real-world clinical experience with octreotide.3
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Treatment-related and treatment-emergent AEs occurring in ≥5% of patients in either treatment group during the randomized phase by system organ class and preferred term§§
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MYCAPSSA Safety Profile Compared to Placebo3
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Adverse Event Data in Patients Who Responded to MYCAPSSA and to iSSAs2‡‡

Treatment-related and treatment-emergent AEs occurring in ≥5% of patients in either treatment group during the randomized phase by system organ class and preferred term§§

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††Includes blood glucose increased, hyperglycemia, and glycosylated hemoglobin increased.
‡‡Data are representative of patients responding to both iSSAs and MYCAPSSA.
§§An adverse event was considered related if the relationship to study drug was reported as possibly related or related.
For Patients With Renal or Hepatic Impairment3
  • Acromegaly is associated with a higher risk for end-stage renal disease and hepatomegaly9-11
  • Patients with end-stage renal disease may initiate MYCAPSSA at a lower 20-mg dose3
  • No dose adjustment is necessary for patients with mild, moderate, or severe renal impairment or for patients with hepatic impairment3
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Important Safety Information

Contraindications

Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.


Warnings and Precautions

MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.

Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

New onset of steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur with MYCAPSSA and other somatostatin analogs. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency and manage accordingly.


Adverse Reactions

The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.


Drug Interactions

The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women taking an oral contraceptive to use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA.

Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.


Pregnancy

Advise premenopausal females of the potential for an unintended pregnancy.

Please report adverse events to Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including Medication Guide.

Indication

Indication and usage

MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

Important Safety Information

Contraindications

Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.


Warnings and Precautions

MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.

Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

New onset of steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur with MYCAPSSA and other somatostatin analogs. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency and manage accordingly.


Adverse Reactions

The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.


Drug Interactions

The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women taking an oral contraceptive to use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA.

Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.


Pregnancy

Advise premenopausal females of the potential for an unintended pregnancy.

Please report adverse events to Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including Medication Guide.

Indication

Indication and usage

MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

REFERENCES: 1. Samson SL, et al. J Clin Endocrinol Metab. 2020;105(10):1-13. 2. Fleseriu M, et al. Lancet Diabetes Endocrinol. 2022;10(2):102-111. 3. MYCAPSSA [package insert]. Chiesi USA, Inc. 2024. 4. Melmed S, et al. J Clin Endocrinol Metab. 2015;100(4):1699-1708. 5. Gordon MB, et al. Endocr Pract. 2021;27(6 Suppl):S131 (Abstract #1041607). 6. Fleseriu M, et al. J Clin Endocrinol Metab. 2023;108(12):3214-3222. 7. Melmed S, et al. Supplemental appendix. J Clin Endocrinol Metab. 2015;100(4):1699-1708. 8. Fleseriu M, et al. Pituitary. 2019;22:581-593. 9. Hong S, et al. Kidney Int. 2023;104(4):820-827. 10. National Organization of Rare Disorders. Acromegaly. Accessed September 11, 2025. https://rarediseases.org/rare-diseases/acromegaly/ 11. Lugo G, et al. Int J Endocrinol. 2012;2012:540398.