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Acromegaly Treatments Compared

Name: Acromegaly Treatments Compared
Creator: Jason Hunter
Published: 2026-10-01

6 FDA-approved drugs and 1 in development, side by side from the current prescribing labels. Newest label Dec 2025. Checked October 1, 2026.

Somatostatin analog injectionsSandostatin LAR Depot · Somatuline Depot · Signifor LAR

Oral somatostatin analogsMycapssa · Palsonify

GH receptor blockerSomavert

Six drugs are FDA-approved for acromegaly, 4 injections and 2 pills. Sandostatin LAR Depot, Somatuline Depot and Signifor LAR are injections every 4 weeks given by a clinician, Somavert is a daily self-injection that blocks the growth hormone receptor, and the 2 oral options are Mycapssa, octreotide capsules twice a day, and Palsonify, a once-daily pill approved in September 2025. Two of the 6 are the same molecule, octreotide, in different forms, and Oclaiz would be a third. The IGF-1 control rates on the labels vary widely, but they come from very different trial designs, so they do not rank the drugs. A monthly self-injected octreotide depot, Oclaiz, has an FDA decision date of December 18, 2026.

Side by side

6 approved acromegaly treatments at a glance

How each drug is given, how often, who it is approved for and when it was first approved, from the current FDA label.

Acromegaly treatments compared: route, schedule, approved use and approval date
Drug	How it is given	How often	Approved for	First approved
Sandostatin LAR Depot octreotide acetate (long-acting injectable) Novartis	Deep injection into the buttock muscle at a clinic	20 mg every 4 weeks for 3 months, then adjusted to 10, 20, 30 or 40 mg every 4 weeks based on GH and IGF-1	Long-term maintenance for acromegaly after inadequate response to surgery or radiation, or when those are not an option, in patients who first responded to and tolerated Sandostatin injection	November 25, 1998
Somatuline Depot lanreotide Ipsen	Deep injection under the skin of the buttock, given by a healthcare provider	90 mg every 4 weeks for 3 months, then 60, 90 or 120 mg every 4 weeks based on GH and IGF-1; some controlled patients can move to 120 mg every 6 or 8 weeks	Long-term treatment of acromegaly after inadequate response to surgery or radiation, or when those are not an option	August 30, 2007
Signifor LAR pasireotide Recordati Rare Diseases	Injection into the buttock muscle at a clinic	40 mg every 4 weeks; may increase to 60 mg every 4 weeks after 3 months if GH or IGF-1 not normal	Acromegaly after inadequate response to surgery, or when surgery is not an option	December 15, 2014
Somavert pegvisomant Pfizer	Daily shot under the skin at home (first 40 mg loading dose given by a clinician)	40 mg loading dose, then 10 mg once daily, adjusted by 5 mg every 4 to 6 weeks to normalize IGF-1; range 10 to 30 mg daily	Acromegaly after inadequate response to surgery or radiation, or when those are not appropriate	March 25, 2003
Palsonify paltusotine Crinetics Pharmaceuticals (Vertex acquisition announced July 2026)	One pill a day at home, on an empty stomach	40 mg once daily, may increase to 60 mg once daily after 2 to 4 weeks based on IGF-1; take at least 6 hours after a meal and 1 hour before the next	Adults with acromegaly after inadequate response to surgery, or when surgery is not an option	September 25, 2025
Mycapssa octreotide (delayed-release capsules) Chiesi	Capsules by mouth twice a day at home, on an empty stomach	20 mg twice daily, increased in 20 mg steps based on IGF-1 up to 80 mg a day; take at least 1 hour before or 2 hours after a meal	Long-term maintenance for acromegaly in patients who have responded to and tolerated octreotide or lanreotide	June 26, 2020

The calendar

A year on each acromegaly treatment

Every dose in a year, drawn to the label schedule, so the difference between a daily pill and a twice-yearly infusion is the picture.

Sandostatin LAR Depot

Injection, at a clinic

13 doses a year

Somatuline Depot

Injection, at a clinic

13 doses a year

Signifor LAR

Injection, at a clinic

13 doses a year

Somavert

Injection, at home

365 doses a year

Palsonify

By mouth, at home

365 doses a year

Mycapssa

By mouth, at home

730 doses a year

Counts follow the label schedule for a full year on the maintenance dose. Drugs given in cycles or adjusted to blood tests have no fixed count, so their schedule is written out instead.

The evidence

What the pivotal acromegaly trials showed

The primary result from the trial each FDA approval rests on, as reported on the label.

Before you compare

How to read the acromegaly trial results

1
The IGF-1 rates are not like-for-like
Sandostatin LAR and Somatuline Depot rates come from open-label studies with no placebo comparison. Mycapssa and Palsonify's second trial enrolled people already controlled on injections, so their rates reflect keeping control, not achieving it. Palsonify's first trial is the only placebo-controlled trial of a somatostatin analog in uncontrolled patients, Somavert's pivotal trial was also placebo-controlled, and Signifor LAR's is the only trial against an active comparator, octreotide LAR.
2
Somavert works differently
It blocks the growth hormone receptor rather than lowering growth hormone, so GH levels rise on treatment and only IGF-1 is tracked.
3
Signifor LAR and blood sugar
Signifor LAR raised blood sugar far more than the other somatostatin analogs: 60% of newly treated patients had diabetes at 12 months in its trial, up from 30% at the start.

Acromegaly pivotal trial results by drug
Drug	Pivotal trial	Primary result
Sandostatin LAR Depot octreotide acetate (long-acting injectable) Novartis	3 switch studies, 261 adults already responding to short-acting octreotide	No placebo arm. In the 12-month study, 67% had normal IGF-1 on both the LAR depot and daily octreotide shots (82 of 122); in the 2 longer studies 51% vs 41% (45 vs 36 of 88)
Somatuline Depot lanreotide Ipsen	Study 1, 108 adults (4-week placebo phase then 1 year open-label)	58% had normal IGF-1 after 1 year (62 of 107); in the 4-week placebo phase 63% had GH fall by more than half vs 0% on placebo
Signifor LAR pasireotide Recordati Rare Diseases	C2305, 358 adults new to drug treatment, vs octreotide LAR Trial record or paper	31% reached both GH under 2.5 and normal IGF-1 at 12 months vs 19% on octreotide LAR; normal IGF-1 alone 39% vs 24%
Somavert pegvisomant Pfizer	12-week placebo-controlled study, 112 adults Trial record or paper	IGF-1 fell 27%, 48% and 63% at 10, 15 and 20 mg daily vs 4% on placebo at week 12; IGF-1 normalized in 54%, 81% and 89% vs 10% on placebo
Palsonify paltusotine Crinetics Pharmaceuticals (Vertex acquisition announced July 2026)	PATHFNDR-1, 111 adults uncontrolled (Study 1); PATHFNDR-2, 58 adults switched from injections (Study 2) Trial record or paper	56% had normal IGF-1 at week 24 vs 5% on placebo (PATHFNDR-1); 83% kept normal IGF-1 at week 36 vs 4% on placebo after switching from injections (PATHFNDR-2)
Mycapssa octreotide (delayed-release capsules) Chiesi	CHIASMA OPTIMAL, 56 adults controlled on injections Trial record or paper	58% kept normal IGF-1 after 9 months vs 19% on placebo after switching from injections; 25% needed to go back to injections during the study

Safety

Acromegaly treatment side effects and warnings

None of these drugs carries a boxed warning. Each label's main precautions are listed.

Acromegaly treatments: most common side effects and key warnings from the FDA labels
Drug	Most common side effects	Key warning
Sandostatin LAR Depot octreotide acetate (long-acting injectable) Novartis	diarrhea 36%, abdominal pain 29% and flatulence 25%	No boxed warning. Gallstones and gallbladder sludge (new gallstones in 22% of acromegaly patients), high or low blood sugar, low thyroid, slow heart rate.
Somatuline Depot lanreotide Ipsen	diarrhea 37%, gallstones 20% and abdominal pain 19%	No boxed warning. Gallstones and complications, high or low blood sugar, slow heart rate, low thyroid.
Signifor LAR pasireotide Recordati Rare Diseases	diarrhea 39%, high blood sugar 29% and gallstones 26%	No boxed warning. High blood sugar and new diabetes, sometimes severe (diabetes rose from 30% to 60% of patients at 12 months); slow heart rate and QT prolongation; liver test rises.
Somavert pegvisomant Pfizer	infection 23% (10 mg group), pain 14% (20 mg group) and nausea 14% (20 mg group)	No boxed warning. Liver toxicity (liver tests required before and during treatment), low blood sugar in people with diabetes, serious allergic reactions.
Palsonify paltusotine Crinetics Pharmaceuticals (Vertex acquisition announced July 2026)	diarrhea 33%, abdominal pain 19% and nausea 9%	No boxed warning. Gallstones and complications, high or low blood sugar, slow heart rate and conduction changes, low thyroid.
Mycapssa octreotide (delayed-release capsules) Chiesi	diarrhea 29%, nausea 21% and vomiting 14%	No boxed warning. Gallstones and complications, high or low blood sugar, low thyroid, slow heart rate.

Not yet approved

Acromegaly treatments in Phase 3 or under FDA review

Investigational drugs with a Phase 3 trial, shown separately because their results are not from a label. Status as of the date in each row.

Acromegaly drugs in development
Drug	Status	How it works and is given	Pivotal trial	Result so far	What is next
CAM2029 (octreotide subcutaneous depot; Oclaiz in the US, Oczyesa in the EU and UK) Camurus	Under FDA reviewas of October 1, 2026	Long-acting octreotide depot (somatostatin analog) with about 5 times the bioavailability of octreotide LAROnce-monthly shot under the skin with a self-injection pen	ACROINNOVA 1, Phase 3, 72 adults (plus ACROINNOVA 2 open-label, 135 adults)Primary endpoint: Proportion with mean IGF-1 at or below the upper limit of normal at weeks 22 and 24 ClinicalTrials.gov	Met primary endpoint: 72.2% had normal IGF-1 vs 37.5% on placebo (ClinicalTrials.gov results; Ferone et al., JCEM 2024)	FDA decision expected by December 18, 2026 (PDUFA date; Camurus press release, July 17, 2026) Camurus press release, July 17, 2026

Cost

Help paying for acromegaly treatment

Drugmaker copay and free-drug programs, plus charity funds for the condition, checked every week.

Questions

Acromegaly treatment questions people ask

Is there a pill for acromegaly?

Yes, 2. Palsonify (paltusotine), approved September 25, 2025, is 1 pill a day on an empty stomach; in its trial 56% of uncontrolled patients reached normal IGF-1 at week 24 against 5% on placebo. Mycapssa (oral octreotide), approved in 2020, is capsules twice a day for people already controlled on injections, and 58% kept normal IGF-1 after 9 months against 19% on placebo.

What is the difference between Sandostatin LAR and Somatuline Depot?

Both are long-acting somatostatin analogs injected every 4 weeks by a clinician. Sandostatin LAR is octreotide given deep into the buttock muscle; Somatuline Depot is lanreotide given deep under the skin of the buttock. In their open-label studies, 67% on Sandostatin LAR and 58% on Somatuline Depot had normal IGF-1 after about a year, with no placebo comparison for the IGF-1 result in either.

When will Oclaiz be approved?

The FDA decision date for Oclaiz (CAM2029, octreotide subcutaneous depot) is December 18, 2026, after a manufacturing-related complete response letter in June 2026 and a resubmission accepted in July 2026. In its Phase 3 trial, 72% had normal IGF-1 against 38% on placebo. It would be the first once-monthly octreotide that patients inject themselves.

Which acromegaly drug has the most side effects on blood sugar?

Signifor LAR (pasireotide). In its trial of newly treated patients, the share with diabetes rose from 30% at the start to 60% at 12 months, far above the other somatostatin analogs.

Go deeper

More on Acromegaly at Trial Friend

Sources

Where every number on this page comes from

Approved-drug facts are from the current FDA prescribing information on DailyMed, with the label's effective date. Investigational-drug facts are from ClinicalTrials.gov and the sources named in each row.

Sandostatin LAR Depot (octreotide acetate (long-acting injectable)) prescribing information, Novartis, label dated Dec 2025. DailyMed
Somatuline Depot (lanreotide) prescribing information, Ipsen, label dated Oct 2024. DailyMed
Signifor LAR (pasireotide) prescribing information, Recordati Rare Diseases, label dated Jul 2024. DailyMed. Pivotal trial: ClinicalTrials.gov
Somavert (pegvisomant) prescribing information, Pfizer, label dated Dec 2025. DailyMed. Pivotal trial: publication
Palsonify (paltusotine) prescribing information, Crinetics Pharmaceuticals (Vertex acquisition announced July 2026), label dated Sep 2025. DailyMed. Pivotal trial: ClinicalTrials.gov
Mycapssa (octreotide (delayed-release capsules)) prescribing information, Chiesi, label dated Jul 2025. DailyMed. Pivotal trial: ClinicalTrials.gov
CAM2029 (octreotide subcutaneous depot; Oclaiz in the US, Oczyesa in the EU and UK), Camurus: ClinicalTrials.gov record; Camurus press release, July 17, 2026. Checked October 1, 2026.

This page compares what the FDA labels and pivotal trials report. It is not medical advice, and no trial on this page compared these drugs with each other. Written and checked by Jason Hunter; the method is on the editorial standards page.